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Search Results Page 1 of 5

Job Post Information* : Posted Date 5 days ago(2023/5/31 09:43)
Responsibilities are within the Human Resources:    - Support for preparing employment contracts/declarations/documentation and the registration of new employee at the local Government entitles - Assist in payroll preparation - Compile and update employee records and time & attendance to ensure accuracy databases - Support on the Onboarding of new Employees and help to ensure that the orientation process and paperwork done is consistent with the Hovione Onboarding Procedure - Assist with day to day operations of the HR functions and duties  
ID
2023-9627
Location
PT-Loures
# of Openings
1
Job Post Information* : Posted Date 3 weeks ago(2023/5/15 11:07)
Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.   - Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready” - Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities - Act as a catalyst for change and improvement in performance/quality - Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR - Provide an example of professionalism and support the induction and training of new colleagues within the area - Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured - Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports - To prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary. - Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits - Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate - To close open deviations and propose CAPAs based on the outcome of periodic follow-ups - Prepares SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate - Approves IOPs, process master documentation and product specifications as required and appropriate. - Ensures that SOPs and IOPs are up to date, compliant and supports efficient production - Review regulatory documentation and co-ordination of site documentation to support regulatory requirements - Authorize the usage of production equipment/utilities when qualification required - Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required - Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate - To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates - To maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required - To approve Validation Master Plans, Process Validation Protocols and reports as required - Accurately use and maintain all information systems - Support the generation / reporting of KPIs for the team. - Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area - Co-ordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes - To provide relevant training to new colleagues, and to the other areas in applicable cGMP, internal procedures and quality systems in accordance with established training plans - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the Quality Assurance tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9593
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 weeks ago(2023/5/12 14:23)
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To maintain good hygiene and housekeeping within the laboratory. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - Be the go-to person for troubleshooting activities. - Drive high standards in the QC Laboratories. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - To propose corrective actions and suggestions for improvements. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Assist with audits as required, following the instruction of QC Management. - Undertake any additional tasks to support the laboratory activities as and when required. - Participate, as required, in the induction and training of new Analysts across Hovione. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
ID
2023-9580
Location
US-NJ-East Windsor
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 5 days ago(2023/5/31 14:50)
Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.   - In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications - Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated - Execute the construction, assembly, commissioning and qualification of Engineering projects - Create the installation plan and maintain a close follow up for Engineering Projects - Guarantee the necessary resources, internal and/or external to meet project plans and to deliver the expected quality on time and on budget. - Define and implement technical solutions for unexpected challenges during the construction, assembly and commissioning & qualification of facilities without compromising the design concept and the process functionality, quality and systems. - Report and escalate promptly any relevant deviations to plans or objectives and make quality and timely decisions within the Engineering tasks under her / his responsibility - Report on a weekly basis the progress of work including any pending items and deadlines. - Be fully aware of specifications, drawings, work procedures and ensure the contractors receive the adequate documentation and training to perform the work correctly - Perform change control assessments as per defined standards and procedures in place - Ensure the change management system is applied correctly and confirm that prior to execution of any additional /extra work caused by scope changes, the proper authorization is obtained - Plan that relevant inspections and tests are performed in compliance with the Project standards or legal requirements - Participate, issue, revise and/or approve commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.) - To coordinate commissioning and/or qualification related activities with involved areas - When applicable, lead the external qualification contractors assuring the optimal use of their time/cost. - Perform preparation of the commissioning and qualification activities in coordination with the involved areas (design engineering, assembly, automation, user area, QC and QAU) according to the defined standard and procedures in place - Guarantee the delivering of commissioned & qualified facilities that can meet user and technical requirements. - Perform deviation investigations and CAPA implementation as per applicable procedures in place - On hand-over, guarantee that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures and customer expectations - Promote a list of pending items with responsibilities and deadlines (punch list) that do not infringe installation compliance with cGMP and HSE guidelines - Support the training of the end user to ensure they make best use of the equipment - Register the user feedback for future learnings - Apply and develop knowledge of Engineering and participate in area processes, procedures and projects with the guidance of more senior colleagues - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Guarantee the compliance to safety and legal rules on the field, coaching all resources involved and liaise with authorities whenever necessary - Participates in audits performed by clients and health authorities, in the scope of the Qualification and Validation area - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with GMP, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
ID
2023-9577
Location
US-NJ-East Windsor
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 3 weeks ago(2023/5/16 15:50)
This role is on-site, East Windsor, NJ and has opportunity for 1st OR 2nd shift available.   Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities. - Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures. - Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations. - Execute and ensure, with autonomy, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities. - Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures. - Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate. - Participate in all necessary training as defined in the training plan. - Report abnormal situations at the installations, as soon as these are detected so that corrective maintenance is triggered in due time. - Identify the necessary corrective and preventive actions to keep, in a proactive manner, the installation in good conditions. - Act as the lead process engineer in multiple projects with limited support and liaises directly with customer project teams. - Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs. - Provide training on manufacturing processes, production systems and procedures to operational team members - Participate, as required, in the induction of new colleagues ensuring they are appropriately trained in accordance with established training plans. - Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operating and high quality performance. - Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable) - Assist with audits and investigations. - Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment. - Contribute to the design of new facilities or to the modification of existing ones. - Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge. - Develop and accumulate strong engineering expertise, sharing knowledge of state-of-the-art technologies and methodologies within the area. - Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools. - Contributes to the increase of productivity by reviewing, proposing, planning and implementing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes. - Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects. - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9576
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 3 weeks ago(2023/5/16 15:53)
This role is on-site, East Windsor, NJ and has opportunity for 1st ~OR~ 2nd shift available.   Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities. - Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures. - Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations. - Execute and ensure, with autonomy, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities. - Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures. - Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate. - Participate in all necessary training as defined in the training plan. - Report abnormal situations at the installations, as soon as these are detected so that corrective maintenance is triggered in due time. - Identify the necessary corrective and preventive actions to keep, in a proactive manner, the installation in good conditions. - Act as the lead process engineer in multiple projects with limited support and liaises directly with customer project teams. - Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs. - Provide training on manufacturing processes, production systems and procedures to operational team members - Participate, as required, in the induction of new colleagues ensuring they are appropriately trained in accordance with established training plans. - Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operating and high quality performance. - Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable) - Assist with audits and investigations. - Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment. - Contribute to the design of new facilities or to the modification of existing ones. - Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge. - Develop and accumulate strong engineering expertise, sharing knowledge of state-of-the-art technologies and methodologies within the area. - Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools. - Contributes to the increase of productivity by reviewing, proposing, planning and implementing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes. - Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects. - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9575
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 3 weeks ago(2023/5/18 15:56)
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   This Process Engineer opportunity is for on-site, 2nd shift (8 h/ M-F) with shift differential bonus.   - Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities. - Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures. - Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations. - Execute and ensure, with autonomy, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities. - Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures. - Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate. - Participate in all necessary training as defined in the training plan. - Report abnormal situations at the installations, as soon as these are detected so that corrective maintenance is triggered in due time. - Identify the necessary corrective and preventive actions to keep, in a proactive manner, the installation in good conditions. - Act as the lead process engineer in multiple projects with limited support and liaises directly with customer project teams. - Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs. - Provide training on manufacturing processes, production systems and procedures to operational team members - Participate, as required, in the induction of new colleagues ensuring they are appropriately trained in accordance with established training plans. - Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operating and high quality performance. - Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable) - Assist with audits and investigations. - Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment. - Contribute to the design of new facilities or to the modification of existing ones. - Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge. - Develop and accumulate strong engineering expertise, sharing knowledge of state-of-the-art technologies and methodologies within the area. - Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools. - Contributes to the increase of productivity by reviewing, proposing, planning and implementing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes. - Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects. - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9574
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 3 weeks ago(2023/5/16 18:37)
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Rigorously, efficiently and professionally, organize and execute all production activities, adhering to all applicable procedures and following instructions received from ascending colleagues. - To execute with autonomy the production processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an advocate for safe operating and high quality performance, alerting ascending colleagues to any potential risks and suggesting production optimizations or improvements. - Develop and accumulate strong production knowledge. - Demonstrate professionalism and willingness to help, upon request, in the induction and training of new operators, sharing expertise and practical knowledge. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production Area in which the TM are allocated). - Maintain clean and organized facilities. - Attend and participate fully in all meetings and training to which the TM is invited - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. The TM is expected to previously assess and proactively propose solutions for the identified issues. - Ensure that all equipment is checked and calibrated before use. - Ensure the correct identification and use of equipment (labels, plates, logbooks etc.). - Prepare and supervise sample process (according to the Area in which the TM is allocated). - Execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.). - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET). - Troubleshoot systems and take appropriate action as required. - Use the Personal Protective Equipment and keep it in good condition. - Collaborate in internal and external audits / inspections as requested. - Actively collaborates in investigations of abnormal/unexpected events. - Follow all annual performance review requirements, including completion of the self-assessment. - Suggest and participate in improvements in the area in which the TM is assigned. - Collaborate in the revision of any area documents as requested (IOPs, others). - Participate, as required, in the induction, training and supporting of new Operators across Hovione. - Collaborate in the integration of the transferred Operators from other areas. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9570
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 4 weeks ago(2023/5/8 15:50)
- To provide financial support on key capital expenditure projects for the business, highlighting risks and opportunities - Key individual in Annual Financial Audit, liaising with external auditors - Involvement in other audits, Revenue/IDA/R&D - Take lead in the weekly/monthly key project meetings finance updates - Involvement in grant Claims process - Aid on continuous improvement projects - Provide Cover for other team members - Participate in annual financial audits, liaising with external auditor - Submit periodical financial information to governmental entities - Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the accounting tasks under her / his responsibility
ID
2023-9569
Location
IE-Cork
# of Openings
1
Job Family
FINANCE
Job Post Information* : Posted Date 1 month ago(2023/5/2 14:47)
Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.   - In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications - Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated - Execute the construction, assembly, commissioning and qualification of Engineering projects - Create the installation plan and maintain a close follow up for Engineering Projects - Guarantee the necessary resources, internal and/or external to meet project plans and to deliver the expected quality on time and on budget. - Define and implement technical solutions for unexpected challenges during the construction, assembly and commissioning & qualification of facilities without compromising the design concept and the process functionality, quality and systems. - Report and escalate promptly any relevant deviations to plans or objectives and make quality and timely decisions within the Engineering tasks under her / his responsibility - Report on a weekly basis the progress of work including any pending items and deadlines. - Be fully aware of specifications, drawings, work procedures and ensure the contractors receive the adequate documentation and training to perform the work correctly - Perform change control assessments as per defined standards and procedures in place - Ensure the change management system is applied correctly and confirm that prior to execution of any additional /extra work caused by scope changes, the proper authorization is obtained - Plan that relevant inspections and tests are performed in compliance with the Project standards or legal requirements - Participate, issue, revise and/or approve commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.) - To coordinate commissioning and/or qualification related activities with involved areas - When applicable, lead the external qualification contractors assuring the optimal use of their time/cost. - Perform preparation of the commissioning and qualification activities in coordination with the involved areas (design engineering, assembly, automation, user area, QC and QAU) according to the defined standard and procedures in place - Guarantee the delivering of commissioned & qualified facilities that can meet user and technical requirements. - Perform deviation investigations and CAPA implementation as per applicable procedures in place - On hand-over, guarantee that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures and customer expectations - Promote a list of pending items with responsibilities and deadlines (punch list) that do not infringe installation compliance with cGMP and HSE guidelines - Support the training of the end user to ensure they make best use of the equipment - Register the user feedback for future learnings - Apply and develop knowledge of Engineering and participate in area processes, procedures and projects with the guidance of more senior colleagues - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Guarantee the compliance to safety and legal rules on the field, coaching all resources involved and liaise with authorities whenever necessary - Participates in audits performed by clients and health authorities, in the scope of the Qualification and Validation area - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with GMP, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
ID
2023-9559
Location
IE-Cork
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 1 month ago(2023/5/2 14:46)
Plan and designs manufacturing facilities and related structures. Determines facility specifications, including analysis and evaluation of location, material resources and structural design. Resolves technical problems and recommends installation improvements to meet process requirements.   - To participate in the user requirements specifications (URS) definition, understanding and supporting the user needs, contributing to achieve an URS adequate for the intended use and also promoting wellbeing of the users, ergonomics and productivity during the use of the installation. - Conceive, design and implement engineering solutions on the specific areas of engineering projects, towards a successful project conclusion, in order to achieve the company established objectives - Support the procurement phase of specific components from bids to good reception confirmation and approving purchase requisitions where assigned. - Prepare, revise and approve technical documentation of Engineering Projects, for conceptual, basic and detailed design phases - Ensure that project documents are complete and optimal for a competitive tender process - Prepare the project budget & timeline, and control them during execution - Prepare Engineering Standards comprising best available and cost-effective solutions, based on proven solutions - Supervise the construction, installation, commissioning and qualification of assigned projects, within is area of responsibility - Support the internal and external Engineering teams, integrating the work with other specialties into the final project solution, assuring user deadlines are met and without unexpected delays in production - Execute all assigned tasks, planning and delivering on time, safely, efficiently, reliably and in a cost-effective manner - Work with the other Engineering areas and project management to resolve project issues, ensuring the delivery/completion of the project work - Capture user feedback and lessons learned for future projects - Propose improvements (procedures, organizational, new technologies, capex, productivity) in Engineering as appropriate - Make quality and timely decisions within the Design Engineering tasks under his/her responsibility - Execute professional activities in compliance with GMP, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Gather relevant data to inform the decision makers regarding complex issues - Create and select the technical documentation to be used as a learning tool for new engineers, a reference for future projects and a historical repertoire (e.g., for assessments and investigations) - Collaborates in internal and external audits - Updates the Area Director of relevant occurrences and trends that may have a significant impact on the business - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Undertake any additional tasks commensurate with the role as and when required
ID
2023-9558
Location
IE-Cork
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 1 month ago(2023/5/2 14:47)
Provide administrative support to employees or groups within the Engineering function. Maintains files, records, calendars and diaries. May arrange business travel, coordinate meeting arrangements and / or track expenses. Uses standard and/or advanced business software applications (e.g Microsoft Office, SAP, documentation control, analytical software) to prepare correspondence, presentations, agenda, minutes, etc.  Prepares technical reports, document or indicators based on specialized documents. Updates planning and communications in support of decisions made.   - Understand policies, procedures and workflows of department, having some technical knowledge. - Participate in reports for the department, collecting, assembling and summarizing information, as well as preparing specific output elements (charts, graphs, tables) - Ensure all Purchasing related data is transferred accurately into SAP. - Complete and maintain purchase information records within SAP. - Raise and receipt of individual purchase orders related to the Purchasing department. - Ensure all Purchasing data is accurately maintained within SAP in line with business monthly KPIs. - Fill complex documents and prepare technical documents of department within prescribed guidelines -   - Troubleshoot administrative problems of department and propose solutions - Act as key user for specific area software or tools, preparing and delivering training, managing accesses and supporting others - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice  
ID
2023-9557
Location
IE-Cork
# of Openings
1
Job Family
ADMINISTRATIVE & GENERAL SUPPORT
Job Post Information* : Posted Date 2 weeks ago(2023/5/22 13:01)
Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including external customers, suppliers, sponsors and team members.    - Manage projects in the allocated area and escalate complex issues to more senior colleagues or managers. - Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned. - Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or company best practices. - Lead the project team to take decisions and influence key stakeholders with integrity. - Participate in project team composition and selection. - Clarify project team roles and responsibilities and enable others to optimize their use of technical, management and leadership skills. - Communicate proactively and effectively internally and externally, building rapport with key stakeholders. - Give timely and specific feedback to the project TMs regularly, both positive and constructive. - Develop knowledge related to PM methodologies, tools and techniques. - Manage complex projects/ analysis with significant impact on business. - Make quality and timely decisions based on multiple sources of data. - Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals. - Follow all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
ID
2023-9554
Location
PT-Loures
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 2 weeks ago(2023/5/23 14:08)
The Key Project Manager is responsible for delivering win-win cost-effective solutions on time and in full through focused teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and Team Members. This role leads the project teams, sets priorities and makes decisions that result in a successful delivery. This position is accountable for the project to come in at or below cost, and increased project revenue from out-of-scope invoices and performance reward invoices while maximizing financial performance and optimizing customer satisfaction are central to the PM’s function. This person is expected to manage the full range of projects and solve complex problems with full autonomy. - Lead the project team, make decisions, escalate, if needed, based on data; influence key stakeholders with integrity. - Clarify project team roles and responsibilities and enables others to optimize their use of technical, management and leadership skills. - Build and sustain motivation of the project TMs and positive dynamics within the project team. Participate in project team composition and selection. - Communicate proactively and effectively, internally and externally, and build rapport with key stakeholders, including Partners' PMs and Sales’ counterpart. - Build consensus and agreement of the communication plan with external and internal interfaces and deliver accordingly. - Provide concise reporting to relevant forums e.g. Tier 2 project review and S&OP cycle, discussing red and yellow flags by exception. - Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with Project Management Hovione Business Rules (HBR). - Solve problems in effective ways, getting to the root cause of any issues and proposing sustainable solutions aligned with company objectives. - Identify partners’ needs, requirements and expectations to define the scope of projects. - Analyze the costs report and question the data, in turn challenging costs and the relevant allocation (including timesheets and operational expenses), taking action to improve cost outcomes irrespective of allocation. Proactively manage and take responsibility of the scope, cost, time, and quality of each project assigned. - Manage profitability and negotiate with areas to allocate the costs as appropriate, e.g. move from project to area cost center aligned with Finance HBR in force. - Plan invoices aligned to the project plan and the PO/Annex X, in order to anticipate cash flow as much as possible within contract boundaries. - Monitor and controls deliverables and orders to invoice and timely request the invoices as appropriate in a shape that matches the bid/Annex X. - Control the scope of the project and timely flags out of scopes; issues scope of work change control, proactively estimates costs for out of scopes based on standards. - Assign invoices for out of scope or for improved delivery performance subject to close coordination with the account manager. - Make high quality decisions fast and at the right level as often as possible. Escalate issues selectively and convey discerning messages, providing judgment and feedback to the business as appropriate. - Promote continuous improvement and periodic evaluation, actively tracking project performance. Measure project team performance and provide qualitative and quantitative input through the evaluation system for the Line Managers of the project TMs to consider it as part of the overall performance evaluation. - Propose innovative solutions, including processes and tools adjusted to the organization and market needs. Implement the PM best practices defined by Hovione. - Create conditions for the future ways of working to reflect the lessons learned. - Run an After-Action-Review after every significant campaign / event and capture, document and share the lessons. - Actively facilitate cost variance analysis as calculated by Site Controllers and feed the lessons into Assessment / 3P team for cost model improvement.
ID
2023-9553
Location
US-NJ-East Windsor
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 3 weeks ago(2023/5/17 11:34)
This person will manage all instrument and electrical maintenance activities at our Loures site, both preventive and corrective. Will also manage our instrument calibration workflow.   - Contribute to the implementation of strategies on the design, acquisition and maintenance of facilities and equipment to guarantee the maximum reliability of the company assets. - Provide technical solutions for unexpected events during the life cycle of installations and return such learnings to the ones in charge for engineering standards. - Advise in the selection outsourced engineering, maintenance or facility contracts and resources to meet site requirements. - Ensure that continuous improvement and lean thinking is used in all departmental activities - Select the best performers for career advancement in accordance with the organization needs. - Manage and support the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies - Establish the annual objectives for all of his/her direct reports and follow up accordingly. - Ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - Guarantee that facilities respect Regulatory, National laws and Health authority requirements. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure compliance with GMP internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs.
ID
2023-9552
Location
PT-Loures
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 3 days ago(2023/6/2 15:22)
We are looking for an experienced and passionate Senior Learning & Development Specialist to join our global Learning & Development team, dedicated to steer and shape Hovione’s overall learning and people development agenda. We are looking for your thought leadership on how to drive effective, transformational people development and make smart use of state-of-the art learning approaches and methods. You are pivotal to boost personal growth by connecting learners to the broader learning ecosystem, integrating internal and external best practices and partnering with internal and external parties.   Main responsibilities   - Play a lead role or project management role on L&D initiatives. Effectively develop and manage project plans through setting effective expectations, communications, and implementation steps, including content development and diverse delivery methods - Ensure the effective design and implementation of the L&D governance and standardized processes (e.g., induction, onboarding) to meet the business needs. - Co-design, develop and enable development programs, solutions, processes, and tools to support people’s development. - (e.g. learning needs analysis; design and execution; measure training effectiveness) in close collaboration with dedicated internal and external learning partners - Stay tuned on emerging best practices in learning, and consider relevant market, society, and technology trends with impact on corporate learning when setting out Hovione’s learning strategy and development focus. - Provide thought leadership on state-of-the art learning methods and approaches and guide our organization on how to translate up-/re-skilling needs into transformational learning experiences. - Offer practical tools and resources to support on the job learning, coaching and mentoring to nurture a growth mindset and anchor a strong learning culture. - Own our new Learning Management System; ensure it enables a smooth, positive learner experience and provides reporting, metrics, and insights to understand Hovione’s learning patterns, to steer learning offerings and to measure the impact of our learning investments. - Support the identification of opportunities for continuous improvement attending to multiple sources of data and work collaboratively on solutions to address them. - Be open and ready to deliver and moderate workshops, experiential training and learning activities yourself.  
ID
2023-9543
Location
PT-Lisbon
# of Openings
1
Job Family
HR
Job Post Information* : Posted Date 2 weeks ago(2023/5/18 17:18)
Provides secretarial / administrative support to employees or groups in the organization. Receives, screens and directs incoming calls, visitors, mail and email. Maintains files, records, calendars and diaries. May arrange business travel, coordinate meeting arrangements and / or track expenses. Uses standard and/or advanced business software applications (e.g Microsoft Office, SAP, documentation control, analytical software) to prepare correspondence, presentations, agenda, minutes, etc. Acts as key user for area specific tools. Prepares technical reports, document or indicators based on specialized documents. Updates planning and communications in support of decisions made.   - Understand policies, procedures and workflows of department, having some technical knowledge - Maintain confidential department records and files - Receive, classify, reconcile, interpret, consolidate and/or summarize documents and information for the department - Fill complex documents and prepare technical documents of department within prescribed guidelines - Participate in reports for the department, collecting, assembling and summarizing information, as well as preparing specific output elements (charts, graphs, tables) - Troubleshoot administrative problems of department and propose solutions - Act as key user for specific area software or tools, preparing and delivering training, managing accesses and supporting others - Ability to choose the appropriate methods or tools - Follow established procedures and processes, with the ability to interpret instructions - Able to resolve many problems, with more complex issues being referred to others - Able to react to changing priorities - Able to help others in prioritizing work - Provide guidance and support to colleagues informally - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes - Suggest and participate in improvements in the area in which the TM is assigned - Act as a subject matter expert to less experienced colleagues - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9541
Location
PT-Loures
# of Openings
1
Job Family
ADMINISTRATIVE & GENERAL SUPPORT
Job Post Information* : Posted Date 1 month ago(2023/4/25 16:59)
  This Operator position is on-site, East Windsor, NJ and is FIRST shift (6:30-3pm).   Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Rigorously, efficiently and professionally, organize and execute all production activities, adhering to all applicable procedures and following instructions received from ascending colleagues. - To execute with autonomy the production processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an advocate for safe operating and high quality performance, alerting ascending colleagues to any potential risks and suggesting production optimizations or improvements. - Develop and accumulate strong production knowledge. - Demonstrate professionalism and willingness to help, upon request, in the induction and training of new operators, sharing expertise and practical knowledge. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production Area in which the TM are allocated). - Maintain clean and organized facilities. - Attend and participate fully in all meetings and training to which the TM is invited - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. The TM is expected to previously assess and proactively propose solutions for the identified issues. - Ensure that all equipment is checked and calibrated before use. - Ensure the correct identification and use of equipment (labels, plates, logbooks etc.). - Prepare and supervise sample process (according to the Area in which the TM is allocated). - Execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.). - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET). - Troubleshoot systems and take appropriate action as required. - Use the Personal Protective Equipment and keep it in good condition. - Collaborate in internal and external audits / inspections as requested. - Actively collaborates in investigations of abnormal/unexpected events. - Follow all annual performance review requirements, including completion of the self-assessment. - Suggest and participate in improvements in the area in which the TM is assigned. - Collaborate in the revision of any area documents as requested (IOPs, others). - Participate, as required, in the induction, training and supporting of new Operators across Hovione. - Collaborate in the integration of the transferred Operators from other areas. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9536
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 2 months ago(2023/4/5 17:44)
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Contribute to the area planning and participate in the methodology definition for the achievement of the tasks allocated to the team  - Propose new methodologies and objectives and the necessary investments and resources taking in account the project demand trends and project requirements  - Assure that the equipment available is used in a productive way - Ensure the fulfilment of all tasks assigned in the Task distribution list of the area - Strive for Right First Time in all tasks assigned to the team - Generate/Report on key performance indicators for the team - Investigate OOS results, deviations, QC Incidents and HSEE events generated in the team and propose the respective corrective/preventive actions when applicable. - Support the QC Management in fostering an environment of continuous improvement and providing leadership in this area by identifying and implementing practices to deliver efficiency cost reduction, quality and service level improvements. - Propose subjects of the training for the Quality Control program based on needs identified in the day to day operations - Ensure that all company COP’s, SOP’s, IOP’s and policies are adhered to by self and staff of the team - Assist with audits/investigations as required - Represent the team in internal, customer-related meetings or audits - Ensure the state of cleanliness, tidiness and organization of the area and related tasks - Supervise the TMs assigned to his/her area of responsibility and distribute work tasks. Provide input to ensure HR processes run smoothly, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies. Ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity - Ensure area goals are properly cascaded to the team - Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2023-9529
Location
US-NJ-East Windsor
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 1 month ago(2023/5/1 17:38)
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To maintain good hygiene and housekeeping within the laboratory. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - Comply with the high standards in the QC Laboratories. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Assist with audits as required, following the instruction of QC Management. - Undertake any additional tasks to support the laboratory activities as and when required. - Seek out additional information when one feels that the available information is not enough. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
ID
2023-9528
Location
US-NJ-East Windsor
# of Openings
1
Job Family
QUALITY