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Job Post Information* : Posted Date 8 months ago(2023/6/21 15:35)
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
2023-9638
Location
US-NJ-East Windsor
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 3 months ago(2023/11/27 15:53)
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.   - Guarantee cGMP compliance within the area, by assuring that all necessary procedures are implemented on the site, according to the products requirements and as established in specific Quality and Technical Agreements - Manage teams and Team Members, ensuring the best organization of work to deliver on the key area objectives - Manage complex cGMP programs - Ensure the best structure, tools and prioritization to allow timely and quality release of products - Ensure that plans are in place to regularly inspect the operational areas to verify compliance with cGMPs - Lead clients and regulatory audits or inspections as required - Manage and evaluate regularly data regarding the Key performance indicators established for the area, ensuring actions are taken whenever there are deviations - Partner with the various areas to identify areas for improvement of how they work together - Support a continuous improvement mind-set within the area to simplify and streamline how things are done within the area - Assure that flexibility and simplicity are achieved through an entrepreneurship mind set and a “opt-in/opt-out” of procedures to meet the “fit for use” approach - Approve complex IOPs, change control documents (PdAs), process and equipment related documentation as required - Coordinate 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, in order to 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 - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives - Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - 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
2023-9606
Location
IE-Cork
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 8 months ago(2023/6/23 11:20)
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 production schedules while managing internal resources (people & equipment) and fulfilling customer requirements.   - Prepare all manufacturing plans for the production lines under their responsibility, managing resources allocation and assigning the members responsible (when applicable) for specific tasks - Establish the annual objectives for all their direct reports and follow up accordingly - Oversee the activities of his/her team, assuring that they have the right resources and the right knowledge to do their job and reach the defined objectives - Support the assessment workflow during projects business evaluation / technical introduction to the area - Develops areas of human expertise regarding manufacturing execution, in all its components (technical and soft skills) - Survey the working conditions of the facilities under their responsibility, making proposals for need of investment. - Revise and approve campaign related documentation, for projects conducted under the supervision of their group - Enforce fulfillment of the Good Manufacturing Practices (GMP) and HSEE policy, by conducting inspections and liaising with other Areas - Assure HSE operational program targets accomplishment - Coordinate and assure on time preventive maintenance program execution and effective / efficient corrective maintenance, for facilities under their responsibility - Coordinate 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, in order to 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 - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with the area’s strategic objectives - Monitor Area´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures  
ID
2023-9604
Location
IE-Cork
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 4 days ago(2024/2/23 13:00)
- Build, lead, and mentor a team of functional academy leads - Lead the development, implementation, and oversight of Hovione Functional Academies. - Responsible for orchestrating the design, execution, deployment, and continuous improvement of functional academies aimed at enhancing the skills and capabilities of our team members across various functional areas. - Collaborate with cross-functional teams, subject matter experts, and external partners to ensure the success of each academy. - Oversee the design and development of curriculum for each academy, ensuring alignment with industry standards, best practices, and organizational objectives. - Oversee and monitor the deliveries against the deployment plan, risks and mitigation actions to ensure success of each academy. - Manages, reports and works with internal stakeholders for collaboration and alignment. - Work closely with subject matter experts to create engaging and impactful learning materials. - Collaborate with internal stakeholders, including functional representatives and HR, to understand specific training needs and ensure alignment with organizational objectives. - Works with each academy lead to establish key performance indicators (KPIs) and relevant metrics for each academy (and/or key programs within each) and assess their impact on individual and organizational performance.    
ID
2023-9600
Location
PT-Lisbon
# of Openings
1
Job Family
HR
Job Post Information* : Posted Date 9 months 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 9 months ago(2023/5/22 13:10)
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 customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.   - Perform and lead the Group Members to perform project management according to the principles defined by industry standard methodologies such as PMI PMPMBOKMBOK and in compliance with internal processes and requirements. - Promote the continuous development of the Project Management Group Members so that they can set and maintain standards of excellence in Hovione project execution and management for all Customers as well as internal stakeholders. - Assure the motivation of the Group Members by encouraging and offering them challenges that lead to an increase of knowledge within the area of Project Management as well as implementation of best practices, standardized approaches and process simplification related with Project execution and management at Hovione. - Contribute for efficiency improvements in other areas that impact directly with the Project Management Group functions. - Ensure proactive and transparent communication internally and with the Customer. - Support definition of invoice schedule CRM CRM and request invoices (RD)CRM CRM according to the Payment schedule defined in the contracts with Customers. - Coordinate TMs 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, in order to ensure TMs TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with the area's strategic objectives. - Monitor the area’s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures. - Ensure compliance with internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedurCOPsCOPs, HBR, SOPs and others) within his/ TMs TMs. - Comply with all applicaGMP GMP HSE HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedurCOPsCOPs, HBR, SOPs and others) within his/ TMs TMs. -  
ID
2023-9420
Location
PT-Loures
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 10 months ago(2023/4/14 21:59)
- Direct the development, growth and ongoing profitability of the site, by ensuring that the site is properly staffed to meet customer demand with the appropriate capabilities to support the business strategies and P&L objectives. - Together with the VP of Technical Operations, Sales and other Hovione functional leaders develop the annual revenue plan and working budget for the site. - Together with the VP of Technical Operations establish the priorities for future investments in the site. - Develop and implement an effective communication strategy to present the technologies and services of the site to customers and build effective liaison/relationships at appropriate levels with customers. - Develop and implement a review and reporting process for the site to evaluate progress against business and budget objectives, and to discuss and decide future priorities and resources. - Ensure future growth of the site through an active involvement with Business Development in developing a R&D pipeline and executing on growth projects. - Drive a culture of continuous improvement through the effective use of Operational Excellence tools and approaches. - Ensure site compliance with GMP standards, with customers and external government agencies and other regulatory requirements. - Ensure compliance with Health, Safety and Environmental policies and regulations. - Develop for approval and deliver the short, mid, and long-term site objectives and KPIs, annual budget and budget plan, in alignment with Hovione strategic objectives. - Manage the team members assigned to the area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, to ensure all team members are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - 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 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). - Define and implement the organizational structure of the NJ site, anticipating or adapting to changing environment. - Represent the Company to external parties.
ID
2023-9408
Location
US-NJ-East Windsor
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 5 months ago(2023/10/13 13:55)
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.   - Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed - Assure that systems/processes/methods are qualified/validated according to their intended use and product requirements - Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities - Support Quality and Operational areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures   - Participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites, as requested by Corporate function  - Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance  - Participate in Conceptual, Basic and Detailed Design Review for Projects of each Hovione Site, and major Projects at any Site for Corporate function, in order to assure GMP compliance with applicable Guidelines, Corporate Procedures and any specific Site requirements   - Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team - Establishes the required qualification activities of new or changed systems and/or facilities within the change control process  - Prepare VMPs for Projects of each Site, collaborate in the VMP for major Projects and support Project’s execution at each site, for Corporate functions - Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic - Review Reports, at Site level Participate in the management of Quality Systems key activities  - Prepare/review Quality Systems methodologies related to the area objectives and provide training for the sites  - Propose qualification/validation related procedures and documents to be followed - Participates or support internal or external/customer audits and health authority inspections - Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility  - Propose improvements to the area as appropriate and solve problems  - Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility  - Gather relevant data to inform the decision makers regarding complex issues  - 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 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
2023-9374
Location
US-NJ-East Windsor
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 7 months ago(2023/8/3 17:24)
Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.   - Propose and implement complex and thorough HSE policies, procedures and guidelines in the areas of expertise as requested. - Create incident reports and perform inspections to ensure conformity in the HSE areas of expertise. - Lead internal audits in the HSE areas of expertise. - Lead audits conducted by external parties. - Propose and implement complex HSE systems and standards to facilitate the capturing and analysis of HSE statistics. - Conduct complex risk analysis in the HSE area of expertise, proposing mitigation plans in the assigned projects. - Lead the investigation of incidents/accidents as required. - Lead regular inspections to the sites under responsibility in the HSE areas of expertise, ensuring conformity with all procedures and guidelines. - Coordinate key HSE projects with operating and other technical units, guaranteeing the execution of the project. - Contribute to the HSE training strategy and propose training goals and contents. - Coach senior members of the company in HSE practices and principles. - Delivery internal training sessions in the HSE areas of expertise to key people in the organization. - Keep abreast of new legislation and regulations in HSE in the regions and area of expertise under responsibility. - Demonstrate track record in HSE. - Solve complex problems with full autonomy. - Make quality and timely decisions based on multiple sources of data and regarding a wide array of subjects. - Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals. - Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization. - 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). - To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures and training.
ID
2023-9355
Location
PT-Loures
# of Openings
1
Job Family
HSE
Job Post Information* : Posted Date 10 months ago(2023/4/20 18:24)
  Delivers win-win cost-effective solutions on time and in full through a Team of Project managers leading focused project 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. Enable and coach the Project Managers to lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.   Main responsibilities:   - Lead the development of the Project Management area vision, strategy and measures, ensuring these are aligned to the overall business, in collaboration with the Senior Director PMO. - Develop and sustain standardized PM processes, implemented in a consistent and repeatable manner. - Oversee the integration of program and project processes - Develop organizational governance frameworks, hierarchies, and relationships - Monitor portfolio, program, and project performance (actual versus planned) and key performance indicators. - Implement a PM continuous improvement system, to optimize the existing processes and adapt to new challenges and realities, in the line with the overall Corporate PMO strategy - Facilitate organization-wide stakeholder engagement and agreement, actively contributing to customer satisfaction - Control area deliverables and ensures they are completed on time and in full and within budget, thereby exceeding customer expectations - Assign program and project managers to programs and projects - Manage 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, in order to 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 - Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives - Prepare and propose for superior approval the annual area budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures. - Active member of the site leadership team influencing the strategic direction of the site and bringing the customers’ perspective to the attention of the SLT - Comply with 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) within his/ her TMs
ID
2023-9346
Location
PT-Loures
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 5 months ago(2023/10/13 12:27)
The IA Senior Manager will lead the audit work and staff, interface with management and generally perform and review required fieldwork. They will execute audits in all locations of the company (this is a global role) to review and evaluate the effectiveness of the internal controls, reliability of the financial reporting as well compliance with internal standards and external laws and regulations.   The role involves up to 10% of travelling time depending on the audit assignment and is a hybrid job position.   - To assess adequacy of internal controls, efficiency and effectiveness of business processes, including identification of control gaps and recommendations for improvement opportunities arising from audit engagements. - To plan, manage and execute audit assignments as per Annual Audit Plan. - To review and finalize audit working papers and audit findings prepared by audit team members. - To manage audit assignments, report progressively on status of engagement and ensure completion of audit assignment as per the Annual Audit Plan / agreed timeline. - To supervise and assist team members in overall execution of targeted testing and risk assessments. - To review and discuss audit findings, recommendation and corrective action plan with responsible personnel, process owner and relevant stakeholder. - To perform follow up audit on findings reported to ensure management action are implemented accordingly. - To periodically engage members of the management team, stay ahead with Company and industry developments and make adjustments to the internal audit activity, if . - To perform any ad hoc assignments and projects as necessary.  
ID
2023-9331
Location
PT-Lisbon
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 12 months ago(2023/3/9 11:13)
- Establish annual plans for improvement in accordance with past performance and company strategic goals; - Define long term targets for Business Transformation Implementation; - Mentor and facilitate teams that are implementing projects and problem solving; - Coach functional area teams in their daily communication meetings, ensuring that defined methods are properly used in all areas; - Coach Lean Leaders and/or Six Sigma Green Belts; - Develop Operational Excellence Training Program and run training sessions across all levels of the company; - Develop a Continuous Improvement (CI) process in the plant that is visible to all e.g. through indicators, working methods and visual management; - Lead projects that result in major business process improvements for the company; - Track and report project results to management, internally and externally; - Work closely with Project Sponsor and Operational Excellence Director to continuously review process and to eliminate barriers in projects; - Ensure that process improvements stay in place over time and assure their sustainability; - Develop site culture initiatives to establish and maintain the operational excellence culture; - Support the execution of Operational Excellence Maturity Assessment and other benchmarking exercises; - Manage complex projects with significant impact on business; - Make quality and timely decisions based on multiple sources of data.
ID
2023-9248
Location
PT-Lisbon
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 3 months ago(2023/11/15 15:23)
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
2022-8915
Location
US-NJ-East Windsor
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 1 year ago(2023/2/14 09:39)
- Defines and implements business processes that assess overall performance, identify business drivers, benchmark against relevant KPIs, identify improvement opportunities and promote business process optimization. - Defines, produces timely and challenges reports that address performance against budget, profitability, cost, efficiency and risk. - Prepare, monitor and control the annual departmental budget under responsibility to ensure expenditure is in line with the company business plan - Administer all departmental financial and operational information in the appropriate systems - Develop and monitor business performance metrics for the department, acting as a partner of managers and directors and understanding the department or area strategic challenges - Execute regular and specific complex reports for the department related with operational and financial KPIs, as requested by managers and directors - Conduct forecasts with financial and operational information - Support project managers within the department, analyzing project costs to ensure that budgeted costs are in compliance - Conduct specific analysis related with the department, improving data reporting and analysis - Provide financial and accounting advice to directors and managers within the department - Master controlling processes and tools - 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 - 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)
ID
2022-8684
Location
PT-Lisbon
# of Openings
1
Job Family
FINANCE
Job Post Information* : Posted Date 2 years ago(2022/5/2 15:27)
- Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. - Recommend the analytical characterization package (Chemical, physical, performance) and control the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. - Promote the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios. - Perform project analytical tasks for complex projects including: method development, method and specification creation; method transfer, protocols and reports preparation. - Solve complex project analytical problems - Determine the amount of work that is required to accomplish a scope of work and propose solutions that meet and exceed the Client’s expectations - Discuss actively with customers on technical and scientific issues - Prepare and discuss complex product specifications - Conduct and supervise analytical investigations and contribute in the definition and implementation of corrective actions - Support audits and client visits - Evaluate and approve materials, supplier/qualification - Master Analytical Chemistry processes and tools - 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 - 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) - 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
2022-8456
Location
PT-Lisbon
# of Openings
1
Job Family
R&D
Job Post Information* : Posted Date 2 weeks ago(2024/2/12 11:35)
- Define key asset management strategy (preventive maintenance plans, identify critical spare parts, optimize spare parts inventories, update equipment BOM);  - Knowledge on condition-based maintenance techniques, such as vibration analysis, NDT for pipping, welding, etc; - Integration of maintenance procedures in the maintenance management system (SAP); - Knowledge on reliability standards RBI, RCM, SIL; - Troubleshoot problems in the event of equipment malfunctions and be able to execute RCA to identify effective corrective actions; - Analytical skills for historical data to identify low performance assets and life cycle analysis to independently equipment overhaul or replacement; - Participate in definition and assure follow-up of key performance indicators (KPI) of maintenance and reliability; - Establish action plans to continuously improve maintenance performance based on state-of-the-art solutions to improve equipment reliability; - Observe and respect national legislation (DL191/2019, DL50/2005); - Guarantee that cGMP rules and procedures are respected within the area, assure that outsource contractors acknowledge internal procedures; - Ensure all assigned tasks are planned and delivered on time, efficiently, reliably and in a cost-effective manner, and with safety first mindset; - Propose improvements to the area as appropriate and solve problems.
ID
2022-8095
Location
PT-Loures
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 9 months ago(2023/5/29 10:25)
- As subject matter expert you will lead multiple pharmaceutical development projects to ensure effective collaboration between internal & external stakeholders to meet the objectives of Hovione and our clients. - Developing drug product manufacturing processes for oral drug products, including scale up, technology transfer and design space definition. - Promote innovation by identifying, evaluating, and recommending new technologies and/or methodologies for Hovione. - Strive to maintain Hovione as specialists in the field of Oral Drug Product Development through patents and scientific papers. - Keep up to date with current global trends in the pharmaceutical industry, using this information to identify areas for improvement and opportunities for growth/investments. - Select, evaluate, and make recommendations for new equipment to ensure practices and methodologies are aligned with state-of-the-art for pharmaceutical development. - Create a knowledge sharing environment by mentoring the wider team in their experiments and by expanding their technical/theoretical knowledge and experience.
ID
2022-7956
Location
PT-Lisbon
# of Openings
1
Job Family
R&D