Performs engineering work in operations, production, construction or maintenance environments. Responsibilities are within the Engineering Family as a generalist or in a combination of disciplines. Understands the roles and workflows of the Engineering and Maintenance functions.
- 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.
- Translate business cascade goals into departmental and individual goals and clearly communicate goals to team.
- Providing leadership and direction to colleagues within the area to ensure that goals, targets and expectations are communicated clearly.
- 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.
- Appraise team performance, coaching team members to elevate their performance through development plans and address poor performance through improvement plans together with HR business partner.
- Select the best performers for career advancement in accordance with the organization needs
- Define and review the list of the area technical competencies and establish training plans to develop such competencies.
- Responsible for generating annual master plans for the area including costs and resource requirements and clearly defining on how success will be measured for the area responsible;
- Ensure execution of engineering or maintenance activities within area of responsibility using excellence asset life cycle approach.
- Manage outsourced engineering, maintenance or facility contracts and resources to meet site requirements.
- Constantly seek for productivity in the group, questioning practices and measuring activity time to enable simplification and productivity gains
- Ensure equipment and processes are engineered, maintained and operated within all local, national, business codes and regulations;
- Create the conditions for own team to meet all predefined KPI’s for area.
- Monitor the area budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- 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.
- 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;
- 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 Change Controls (PdAs) to assure timely closure of deviations and approval of PdAs, as appropriate;
- Prepares SOPs, department IOPs, quality related reports and change control documents (PdAs) as required and appropriate;
- Review process master documentation, revision of executed batch documentation and product specifications as required and appropriate;
- Review regulatory documentation and co-ordination of site documentation to support regulatory requirements;
- Authorize the usage of production equipment/utilities when qualification required.
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.
- Apply and develop knowledge of Quality Control and participate in area processes, procedures and projects with the guidance of more senior colleagues
- Rigorously, accurately, efficiently and professionally manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations, escalating as appropriate
- Propose new methodologies taking into consideration project demands and requirements
- Execute project specific analytical tasks and act as a stakeholder liaison
- Provide an example of professionalism and support the induction of new colleagues within the area
- Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning
- Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period
- Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team (with support from senior colleagues) as appropriate
- Reviews work generated by the team as required ensuring all procedures are followed
- Creation, investigation and evaluation of CAPAS, incidents and deviations
- Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments
- Accurately use and maintain all laboratory information systems
- To maintain good hygiene and housekeeping within the laboratory
- To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures
- Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities
- 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
- Assist with audits / investigations as required, following the instruction of QC Management
- Support the reporting of KPIs for the team, if required - Develop and accumulate strong analytical chemistry expertise
- Maintain high standards in the QC Laboratories
- Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others
- Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data
- Work collaboratively in cross-functional teams and understand each departments function and role in delivery of tests and products
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner
- 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.
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
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.
Delivers excellence in end-to-end process improvement practices, methodologies and behaviours to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviours and enable alignment of priorities across areas. Supports the continuous improvement cycle aiming at the sustainable increase of unitary output (effective throughput per resource unit used). Responsible for developing, deploying and maintaining the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviours to enable engagement; as well as for deriving metrics to measure plant and equipment capacity to support identification of equipment and process flow bottlenecks, contributing to improved layouts whilst assuring compliance with established guidelines.
- Implement productivity actions and define priorities within own work to achieve the proposed goals (efficiency, efficacy and cost consistency)
- Drive, manage and train the teams that will take part on Continuous Improvement Initiatives, problem solving and risk assessment groups
- Coach operational teams in their daily communication meetings, ensuring that defined methods are properly used in all areas
- Support the development of Operational Excellence Training Program and run training sessions
- Update the productivity indicators of the plant
- Support a Continuous Improvement process in the plant that is visible for all, through indicators, working methods, visual management, etc.
- Ensure the constant reduction of the time and costs required in all activities in Manufacturing
- Ensure that all operational staff are trained according to Operational Excellence training procedures in place
- 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 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)
- 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.
Key roles for this person:
- Perform audit trail review of analytical softwares, as per defined procedures
- Develop and validate formulas in analytical softwares to allow for automatic calculations
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.
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, execute all production/HSE activities, adhering to all applicable procedures and following instructions received from ascending colleagues.
- To execute, with supervision, the production/HSE 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/HSE optimizations or improvements.
- Develop and accumulate strong production/HSE knowledge.
- Demonstrate professionalism in the workplace.
- 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/HSE 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.
- Suggest and participate in improvements in the area in which the TM is assigned.
- Ensure that all equipment is checked and calibrated before use.
- Ensure the correct identification and use of equipment (labels, plates, logbooks, etc.).
- Prepare samples (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 the Personal Protective Equipment and keep it in good condition.
- Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET).
- Collaborate in the revision of any area documents as requested (IOPs, others).
- Collaborate in internal and external audits / inspections as requested.
- Participate, as required, in the induction and training of new Operators across Hovione, Collaborate in the integration of the transferred Operators from other areas.
- Follow all annual performance review requirements, including completion of the self-assessment.
- 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.
Delivers excellence in end-to-end process improvement practices, methodologies, and behaviors to achieve transversally operational and support services areas’ efficiencies. Supports the continuous improvement cycle aiming at the sustainable increase of unitary output (effective throughput per resource unit used). Participation in the development, deployment, and maintenance of the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviors to enable engagement; as well as for deriving metrics to measure plant and equipment capacity to support identification of equipment and process flow bottlenecks, contributing to improved layouts whilst assuring compliance with established guidelines.
- Develop and apply knowledge of process optimization and participate in area processes, procedures optimization projects with the guidance of more senior colleagues
- Take part in Continuous Improvement Initiatives, problem solving and risk assessment groups
- Deliver training on concepts as per training plans in place
- Ensure that all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner
- 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.
Promotes and sells a portfolio of products and/or services and solutions directly to current and new end customers. Informs customers of new product/service introduction and prices. Creates, monitors and revises lead generation plans to ensure a substantive sales opportunity pipeline. Negotiates, with autonomy, highly complex contracts.
- Achieve and deliver personal sales targets, maximizing profitability of new business
- Prospect for new customers and projects through professional means, including (but not limited to) existing networks, trade shows, introductions and LinkedIn
- Develop, maintain and improve, as applicable, relationships with key contacts and decision makers at all prospective customers to ensure visibility of project opportunities as and when they arise
- Follow-up on key new business enquiries with high potential
- Lead relationships with colleagues in different countries and job functions to ensure enquiries from new or potential customer are responded to accurately and promptly
- Coordinate and/or prepare and issue bids against business opportunities identified with prospective customers, identifying and winning projects that fit Hovione´s available resources and manufacturing capacity
- Analyze data, including opportunities with prospective customers, within Hovione´s Customer Relationship Management system for Europe to ensure accurate forecasting
- Participate in negotiations of CDAs, Master Service Agreements and Commercial Supply Agreements for allocated accounts in close collaboration with the Senior Director of the area
- Create and monitor targeting maps and plans for the assigned region
- Support the development of competitiveness mitigation strategies, which include (but are not limited to) investigating collaboration agreements, partnering approaches and other potential in-licensing deals
- Identify complex market trends and demands and proposing ideas for new products and services
- Identify new critical opportunities for the existing product and / or services portfolio and linking with the Account Management team as appropriate
- Monitor customer account and market activity and provide concise and insightful analysis on customer dynamics, market developments and competitor activity
- Coordinate and/or prepare complex reports and data analytics
- Attend and represent Hovione at key Trade Shows
- Develop and accumulate strong and extensive Hovione product and service expertise, sharing knowledge of offerings and cross-selling as appropriate
- 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 Sales strategic objectives
- Monitor own 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
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.
- Ensure the effective and proactive flow of information and requests between the QC team and the internal and external (if applicable) stakeholders
- Participate in meetings with internal and external customers as representative of analytical area, providing information on the status of activities
- Provide collaborative and timely support in the resolution of analytical problems relating to assigned projects / initiatives
- Propose and prepare changes to QC procedures or analytical methods for onwards approval and implementation
- Assure product specifications are maintained in accordance with appropriate standards and propose revisions as required
- Issue and follow-up change controls
- Assure good functioning equipment, planning and managing the maintenance, internal calibration plans, reference standards and internal qualifications of designated laboratory instruments
- Accurately use and maintain all laboratory information systems, participating in the implementation of lab systems improvements as required
- Prepare protocols, reports, QC documentation and review records to ensure compliance with cGMP and HSEE standards
- Request quotations and propose the acquisition of instruments, materials and reagents to guarantee the stock control and operation of the laboratories
- Manage reserve/retention samples
- Initiate events and deviations in the CAPA system in accordance with the required timeframes and in partnership with appropriate colleagues, complete relevant section/s of the event or deviation
- Lead and participate in root-cause investigations, guiding colleagues (as required) in the necessary investigative testing, and ensuring appropriate corrective and preventative actions are determined
- Determine the root cause of events and deviations based upon the data and information obtained through the investigation, ensuring appropriate corrective and preventative actions are determined
- Complete or support the completion/close out of OOS/OOT laboratory deviation investigations and QC incidents
- Monitor progress and follow-up corrective and preventative actions
- Monitor the status of open events and deviations and provide periodic status reports to QC management
- Assess the impact of changes to facilities/systems/equipment/stability and processing of change control documents
- Perform periodic checks of laboratory documentation to ensure compliance with applicable operating procedures and identify and implement updates/improvements to current procedures
- Be an advocate for safe operating and high-quality performance within the area, alerting the management of the area to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements
- Prepare and participate in internal/external audits as requiredSupport the compilation of audit responses for QC
- 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
- Make quality and timely decisions within the 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.
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
You will support the Global Total Rewards team with the development and implementation of the Total Rewards initiatives such as job architecture, competitive compensation, mobility, recognition, perquisites and benefits programs, HR systems and strategic rewards projects.
The responsibilities include but are not limited to:
• Preparate compensation analysis to support individual pay movements and potential total rewards practices adjustments.
• Partner with Total Rewards, HRBP’s and HR operations teams in the execution of annual processes (annual bonus, salary review, executives review).
• Support the design, implementation and roll-out of new/enhanced total rewards policies & procedures and processes.
• Conduct market research, analyze market intelligence and apply data analytics for total rewards initiatives.
• Support in delivering the monthly HR reports to the internal clients.
• Get involved in salary benchmarking, job creation and updates and reporting external entities.
• Assist with HR Systems testing, communication and roll out/implementation of new features/modules.
• Support any ad-hoc Total Rewards projects or initiatives as requested.
• Organize Total Rewards shared drives/platforms.
• 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.
• Carries 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.
Performs engineering work in operations, production, construction or maintenance environments. Responsibilities are within the Engineering Family as a generalist or in a combination of disciplines. Understands the roles and workflows of the Engineering and Maintenance functions.
- Supervise the timely execution of maintenance and calibration of all mechanical / electrical / instrumentation systems on site as per Standard Operating Procedures and Engineering work instructions
- Support the selection of outsourced contractors and supervise their work when required, formally receiving the finished works
- Provide support to the Engineering and Maintenance teams to maintain, improve, troubleshoot, calibrate and service a wide range of equipment and utility services
- Evaluate drawings for local engineering projects
- Ensure the fastest response to corrective maintenance, delivering the best technical solution with the least cost
- Encourage periodic meetings with the Operations team to manage the work of the area.
- Ensure proper maintenance and update of all relevant calibration and maintenance records
- Encourage the proposal of ideas that can increase productivity and/or decrease cost, assess and implement as appropriate, and involving other Managers as relevant
- Provide feedback in regards to the maintenance plans proposed, actively participating in the improvements
- Assure the correct implementation of lean tools in the area (TOP 5; TPM; 5S; 8D)
- Ensure the cleanliness and orderliness of the area
- Assist when required in internal and external audits and participate in deviation investigations
- Assists with training of new starts, apprentices or any relevant TM in the team in regards to technical topics and in our systems and procedures
- 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
- Responsible for continuous training in the workplace to team members under his/her responsibility, including training for upward mobility, in order to guarantee the career development objectives, competence, safety, quality and productivity of the area. Ensure area goals are properly cascaded to the team
- 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 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
Performs maintenance on equipment and systems (e.g., mechanical, electrical). Evaluates and recommends equipment improvements to increase reliability, capability and yield. Performs equipment condition analysis (during preventive and unscheduled maintenance). Troubleshoots and diagnoses equipment problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures.
- Guarantee the execution of the preventive maintenance plan on production equipment
- Troubleshoot problems in the event of equipment malfunctions and be able to recommend solutions for the effective repair of the same
- Establish preventive maintenance plans for new equipment
- Participate, control and correct budget activities
- Optimize external contract costs, including outsourcing activities that could generate high costs of maintenance
- Participate in definition and assure follow-up of key performance indicators (KPI) for production equipment performance, as well as, for outsourcing services
- Optimize spare part inventories, resizing stocks based on breakdowns historical data
- Constantly keep updated equipment spare parts lists, adding whenever necessary new spare parts to the equipment BOM
- Establish action plans to continuously improve maintenance performance based on state-of-the-art solutions to improve equipment reliability
- Guarantee the cleaning and orderliness of areas under his responsibility
- Promote good maintenance practices in the area
- Observe and respect national legislation
- Provide the best technical support to area members
- Coordinate with other areas the fulfilment of plans
- Motivate users for the efficient use of utilities
- Guarantee that cGMP rules and procedures are respected within the area, assure that outsource contractors acknowledge internal procedures
- Ensure that SAP data base is updated with new information when necessary
- 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 Maintenance 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, 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.
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
- Receive, classify, reconcile, interpret, consolidate and/or summarize documents and information for the department
- Fill documents and prepare administrative documents of department within prescribed guidelines
- Participate in simple 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 communicate issues
- Follow procedures with clear instructions
- Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests
- Able to prioritize own work
- 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
- 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.
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.
- Manage projects in the allocated area and escalate complex issues to more senior colleagues or managers. It is recognized that the level of support required will increase when projects that are more complex are assigned. Project assignment will always be based on business need, however, preferentially, projects assigned will have a low to medium degree of complexity including:
- a low to medium cumulative sales / project cost value
- a low to medium to high project control level
- up to a medium customer segmentation level
- 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 or to decide to escalate the decision based on data
- Contribute to the project team composition and selection
- Clarify project team roles and responsibilities
- Communicate proactively and effectively internally and externally
- Build and sustain motivation of the project TMs and positive dynamics within the project team
- Give timely and specific feedback to the project TMs regularly, both positive and constructive
- Keep up to date on the best PM practices, standards and methodology in use within the industry
- 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 project management tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- 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)
- 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
- 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.
- Coordinate the implementation of new procedures.
- Enforce fulfillment of the GMP and HSE policy, by supporting inspections and liaising with other Areas.
- 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)
- Prepare manufacturing plans for production lines, managing resources allocation and assigning the members responsible (when applicable) for specific tasks.
- Responsible for the accurately and timely preparation, review and approval 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.
- Supervise, execute and ensure, with autonomy, all risk assessments for assigned activities and projects
- 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.
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.
- Act autonomously as the lead process engineer in multiple projects of high-complexity and/or with significant impact on business and liaises directly with customer project team, promoting active and transparent communication, including in complex situations.
- Provide training on manufacturing processes, production systems and procedures to operational team members.
- 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)
- Support commercial assessment requests for business evaluation / technical introduction within the area.
- Assist with audits and investigations as SME for Operations.
- Approve changes to facilities and/or equipment trains, when delegated by n+1.
- Promote the transfer of strong engineering expertise amongst other members of team, 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, coordinating and leading the implementation of new technologies, methods and
- Implement the actions derived from approved Area budgets, contributing to costs control and to the achievement of P&L targets.
- 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.
- Coordinate the implementation of new procedures.
- Enforce fulfillment of the GMP and HSE policy, by supporting inspections and liaising with other Areas.
- 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)
- Prepare manufacturing plans for production lines, managing resources allocation and assigning the members responsible (when applicable) for specific tasks.
- Responsible for the accurately and timely preparation, review and approval 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.
- Supervise, execute and ensure, with autonomy, all risk assessments for assigned activities and projects
- 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.
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.
- Act autonomously as the lead process engineer in multiple projects of high-complexity and/or with significant impact on business and liaises directly with customer project team, promoting active and transparent communication, including in complex situations.
- Provide training on manufacturing processes, production systems and procedures to operational team members.
- Oversee the activities of less experienced Engineers, ensuring that they have the right resources and the right knowledge to do their job and to reach the defined objectives.
- 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)
- Support commercial assessment requests for business evaluation / technical introduction within the area.
- Assist with audits and investigations as SME for Operations.
- Approve changes to facilities and/or equipment trains, when delegated by n+1.
- Promote the transfer of strong engineering expertise amongst other members of team, 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, coordinating and leading the implementation of new technologies, methods and
- Implement the actions derived from approved Area budgets, contributing to costs control and to the achievement of P&L targets.
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
- Receive, classify, reconcile, interpret, consolidate and/or summarize documents and information for the department
- Fill documents and prepare administrative documents of department within prescribed guidelines
- Participate in simple 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 communicate issues
- Follow procedures with clear instructions
- Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests
- Able to prioritize own work
- 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
- 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.
Provides support and services in relation to the identification, development and implementation of new systems and enhancement of existing systems. Assesses and/or develops program logic for new IT solutions or analyses and modifies logic in existing systems. Codes, tests, debugs, documents and implements solutions. Analyses requirements, tests and integrates solution components. Ensures that system improvements are successfully implemented. May test new code and typically works in a high efficient “Agile” development environment. Prepares communications and makes presentations on system enhancements and/or alternatives.
- Create, revise and monitor complex product roadmaps according to the strategic goals, the user requirements and the functional specifications, working in partnership with IT business analysts, acting as a leader of the product functional design process
- Define scope and backlog items of software development projects, guiding the application developers and managing the release/sprint goals
- Ensure the application developers have an adequate amount of prior prepared tasks to work on
- Possess a full understanding of end-to-end customer experience integration and dependencies, gathering information from UI/UX specialists and other sources, and communicating to application developers
- Lead the visioning and concept development of products, collaborating with other stakeholders and acting as a product and innovation ambassador
- Prioritize, develop and maintain an appropriately prioritized backlog of user stories for implementation
- Review and/or develop detailed specifications for the product features so they are understood by the application developers
- Lead the planning product release and set the expectations for delivery of new functionalities, reconciling the short, medium and long-term delivery
- Create and continuously update a product inventory, reviewing and auditing products regularly, to identify issues and propose enhancements and innovations
- Work with cross-functional teams and different stakeholders throughout the length of product development, articulating different needs and expertise
- Research and analyze market, competitors, the industry, the users and other relevant data continuously
- Act as the voice of the customer to guide all stages of software development, including user story development, sprint planning, and prioritization of the product backlogMaster agile/scrum processes and tools, keeping abreast with new trends
- 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
- Comply with all IT governance, standards and policies in practice in Hovione
- 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.