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  - To develop, set and implement Process Validation/Product Performance Qualification (PPQ) and Continued Process Verification (CPV) procedures using Risk Management tools. - To oversight Validation status of Hovione's products looking for improvements and rationalization of activities. To establish and monitor product performance indicators and analyze trends. - To assure compliance with the standards set for Product Lifecycle in all Hovione's Sites. - To improve Hovione's Quality System either for including new methodologies, modern pharmaceutical technologies implemented or for standardizing and simplifying procedures and practices. - To open and maintain active and efficient communication channels with each Site QA in order to implement the best practices, across Hovione. - To keep the area up to date with Process Validation (PPQ)/QRM , and Cleaning guidelines, assuring internal training and documentation revision.                                         ** CVs in English only**  

Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.   - Conduct routine tasks with regular supervision - Operate basic equipment and/or machinery - Follow detailed instructions - Resolve routine issues and report non-routine tasks to others - Rigorously, accurately, efficiently and professionally execute and record all activities in accordance with the applicable requirements and guidelines at RD analytical development laboratories, quality operational standards / procedures and legal regulations and following instructions received from ascending colleagues - Testing may be required for the following (non-exhaustive) sample types; in-process control, intermediates, raw materials, new supplier samples, stability (informal) and finished products in a RD analytical development environment - Strive for Right First Time and Productivity in all assigned tasks - Follow safe operating and high-quality performance, alerting peers and ascending colleagues to any potential risks and suggesting optimizations or improvements - Develop and accumulate strong analytical technical expertise - Display professionalism to colleagues - Maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable standard and in accordance with Hovione internal procedures - Maintain good hygiene and housekeeping within the laboratory - Perform routine calibration, verification and applicable preventive/corrective maintenance of designated laboratory instruments - Issue notifications for maintenance/repair to qualified areas, requesting consumables whenever needed - Comply with the high standards in R&D analytical development Laboratories. - Ensure appropriate communication with other internal departments in relation to analytical work by using the appropriate Hovione processes - 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 periodic performance review requirements, including completion of the self-assessment. - 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 team member is assigned - 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.

Promote one single source of truth, data highly reliable and up to date, best in class tools and practices to enhance productivity and the ability to manage costs. Facilitate cross-functional Sales and Operations Planning (S&OP, mid-term horizon) and Execution (short-term horizon) processes to create tensions and deliver best compromises in terms of supply response to demand forecast. Establish plans with appropriate granularity and firmness depending on horizons (mid, short-term horizons and execution), providing supply scenarios to demand, considering production and support areas capability and the best efficiency of resources' usage (people, equipment and materials), based on demonstrated performance.   - Create shift detailed schedule (30) / weekly plan (H90 & H700) for the whole portfolio to answer demand, having into account production and support areas constraints - Review and analyze the allocated resources (human resources, materials and/or processes) to comply with plan - Anticipate and monitor potential scheduling/planning and data management challenges, taking actions to mitigate risks; troubleshoots scheduling /planning / data problems; facilitates and actively contributes to H700H90 and H90H30 meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies - Optimize the plan, ensuring the existence of resources for the continuous production and maximizing efficiency - Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update; - Monitor performance and apply action plans to improve result of KPI's related to Planning/Scheduling process, mainly: Plan Adherence, Campaign Lead Time Adherence, Batch Execution Adherence, Batch Finish Date Adherence, Shift Performance, BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy - Create periodically reports detailing the status of critical activities of on-going projects and KPIs - Promote one single source of truth, data highly reliable and up to date, best in class tools and practices - 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 operations planning and data management tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - 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)

As a Supply Chain Global Planning Trainee at Hovione, you will play a vital role in supporting the comprehensive understanding and optimization of our end-to-end Global Supply Chain for Products and Services. You will have the opportunity to directly collaborate with diverse teams across various sites, including Manufacturing, R&D, Quality, Project Management, and more. Key Responsibilities: - Collaborate with cross-functional teams to identify, analyze, and recommend improvements in end-to-end supply chain processes. - Support digitalization initiatives by assisting in the implementation and integration of digital tools and technologies to enhance supply chain efficiency and effectiveness. - Conduct data analysis to identify trends, patterns, and insights that can drive informed decision-making within the global planning team. - Provide proactive support to the team in various projects, ensuring tasks are organized and executed in a timely and efficient manner. - Collaborate with team members to develop and document standard operating procedures (SOPs) and best practices for supply chain planning activities.

  As a Supply Chain Global Logistics Trainee at Hovione, you will play a vital role in supporting the comprehensive understanding and optimization of our end-to-end Global Supply Chain for warehousing & Transportation. You will have the opportunity to directly collaborate with diverse teams across various sites, including Manufacturing, R&D, Quality, Project Management, and more. Key Responsibilities: - Assist with data collection and analysis to identify areas for process improvement within the logistics department. - Participate in process mapping exercises to document and visualize current workflows. - Research and propose innovative solutions for improving efficiency, reducing waste, and optimizing logistics operations. - Support the implementation of process improvement initiatives, including creating training materials and assisting with change management. - Maintain accurate and up-to-date documentation of processes and procedures. - Collaborate effectively with cross-functional teams, including warehouse personnel, transportation providers, and other logistics stakeholders.

- Organize and execute Production activities; - Be responsible for operating the equipment, keeping the facilities under your responsibility clean and organized; - Ensure that the equipment is checked and calibrated before being used; - Ensure the correct identification and use of equipment (labels, signs, logbooks); - Prepare samples of intermediate products and final products; - Maintain Personal Protective Equipment in good condition; - Use computer programs correctly; - Collaborate in the review of documents in the area; - Collaborate in internal and external audits/inspections; - Participate in the training of new Operators (Production, GMP, HSEE).

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.   - Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready” - Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities - Act as a catalyst for change and improvement in performance/quality - Provide an example of professionalism and leads the induction and training of new colleagues within the area - Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR - Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured - Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports - To authorize the release for sale of finished products (applicable to site without QP) - Prepare for and support internal and external site audits and inspections, leading 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, taking a lead on the most complex situations - Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate - Close open deviations and propose CAPAs based on the outcome of periodic follow-ups - Prepare SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate - Approve IOPs, process master documentation and product specifications as required and appropriate. - Ensure that SOPs and IOPs are up to date, compliant and supports efficient production - Review regulatory documentation and co-ordination of site documentation to support regulatory requirements - Authorize the usage of production equipment/utilities when qualification required - Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required - Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate - Assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates - Maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required. - To approve Validation Master Plans, Process Validation Protocols and reports - Accurately use and maintain all information systems - Support the generation / reporting of KPIs for the team - Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area - Coordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes. - Lead the development and sign-off of training materials and provide relevant training to new colleagues, and to the other areas in applicable cGMP, internal procedures and quality systems in accordance with established training plans - Proactively lead the provision of support to less experienced colleagues in the undertaking of their duties - 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, including those that have the potential to mitigate unnecessary complexity - Master Quality Assurance 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) - 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.

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.

- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities; - Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures; - Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, and other GMP related documentation for all processes run in operations; - Participate and ensure, with supervision, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities; - Report abnormal situations at the installations, as soon as these are detected, so that corrective maintenance is triggered in due time; - Takes lead on non-complex projects / campaigns (with guidance) and supports the lead process engineer in complex projects / campaigns; - Act as a delegate of the lead process engineer and takes an active role liaising with Hovione and customer project teams; - Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs; - Provide training on manufacturing processes to operational team members ensuring they are appropriately trained to perform the process related tasks; - Follow all annual performance review requirements, including completion of the self-assessment.

This is a 3rd Shift Position- 9:30pm to 6am    Coordinates inbound and outbound logistical operations being accountable for the imports and exports of goods and also information flows supporting these operations. Manages inventory, warehousing operations, regulate warehouse space, including reception, pathway, sampling, dispensing and arrange shipments, and local transportation to ensure an efficient supply of goods. Administers an effective system that meets the organization’s inventory targets through efficient and transparent flow of information and materials, including raw materials, intermediates, finished products and spare parts.   - Coordinate warehouse tasks and TMs, implementing all applicable procedures making sure the assigned resources are selected, packaged, loaded and/or dispatched safely, timely and efficiency - Promote productivity and safety in warehouse activities, by daily scheduling tasks of operators. - Monitor warehouse operations according to HSE practices, cGMP, cGDP compliance and quality policy - Ensure that inventories are made and recorded according to procedures - Maintain records of resources handled according to established processes - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks and suggesting process optimizations or improvements - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - Collaborate in the training of warehouse teams, mainly supporting in the organization of training schedules for the team and ensuring attendance - Supervise the TMs assigned to his/her area of responsibility and distribute work tasks. - Provide input to ensure HR processes run smoothly, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies. - Ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity - Ensure area goals are properly cascaded to the team - 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 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

Act as servant leaders developing, coaching and supporting team members aligned with Hovione Supply Chain vision, mission and strategy. Promote cross-functional collaboration, effective communication and critical thinking to be able to improve rigor, discipline and predictability. Implement best practices and leverage on opportunities of standardization and harmonization between areas and sites based on continuous improvement and learning culture.   - Create a long-term strategy for the Global Supply Chain department (including all sites), defining and monitoring the annual plan and adjusting priorities throughout the year, maintaining an even workflow using all resources effectively - Partner with other members of the company´s leadership team to identify how supply chain - can help the company achieve its business and financial goals - Define complex strategies to solve supply chain challenges in the site, acting as a partner of production, maintenance, R&D and engineering - Approve Supply Chain governance, standards and policies in practice in Hovione, guaranteeing an alignment between business goals - Define key metrics for global Supply Chain management in terms of scheduling, planning, master data, inventory and logistics - Oversee global/company-wide supply chain projects, giving direction and coordinating strategic activities, in order to improves processes and systems - Give direction and establish strategic partnerships with key service suppliers, leading the relationship - 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 Global Supply Chain 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. - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - 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 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.

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.   - Implement 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. - Conduct internal audits in the HSE areas of expertise. - Coordinate audits conducted by external parties. - Assist in development and implementation of HSE systems and standards to facilitate the capturing and analysis of HSE statistics. - Conduct risk analysis in the HSE area of expertise, proposing mitigation plans in the assigned projects. - Give support in the investigation of incidents/accidents as required. - Conduct regular inspections to the sites under responsibility in the HSE areas of expertise, ensuring conformity with all procedures and guidelines. - Delivery internal training sessions in the HSE areas of expertise. - 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 HSE 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). - 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.

Defines and implements procedures and processes to assure that Hovione Computerized systems are fit for purpose and comply with applicable quality and data integrity standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and data integrity requirements 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.   - Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH)  - Participate in project teams that require expertise in Computerized Systems. - Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality  - Implement the defined policies for Computerized Systems life cycle Management  - Perform validation activities of the Computerized System projects and provide the necessary guidance to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle  - Implement data integrity principles during the Computerized System life cycle, as defined - Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Analytical equipment, Manufacturing equipment, DCS, PLC and other stand-alone software  - Issue, review and approve protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Validation of Computerized Systems and other validation/qualification documents  - Review/approve/close corporate Computerized System change controls, deviations, incidents submitted by any Department/Site, to ensure that the system is maintained in an accurate, validated, and compliant state - Review/approve documentation regarding Computerized Systems data integrity and its life cycle management  - Provide training and coaching in quality culture and data integrity principles regarding Computerized Systems. - Support internal, external/ customers’ audits and health authorities’ inspections. - Perform assigned tasks as planned and deliver on time, safely, efficiently, reliably and in a cost-effective manner  - Propose improvements to the area as appropriate and solve problems  - 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)

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.   - Plan, coordinate and supervise the work, with other managers of the area, and manage own team to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external) - Assure that all TMs of the team have suitable training in order to guarantee the best possible support to the customer (internal and external) - Ensure an appropriate information flow between the laboratory and the several internal and external customers - Participate in external and internal audits - Approve analytical test methods, reports, protocols and other documents related to the laboratory (as applicable) - Approve raw material, intermediate and finished product batches, stability samples, validations and/or all samples sent for QC to perform analysis - Approve In Process and COL samples when necessary - Assure the availability of International standards and Hovione internal working standards with adequate calibrations/qualifications - Manage International/In-house Primary and Secondary/Clients' standards and reserve/retention samples - Assure the qualification of the laboratory equipment and validation of analytical methods, approving the protocols and / or respective reports - Discuss and propose specifications for raw materials, and intermediate and finished products - Ensure proper management of all defined stability programs in terms of protocol preparation, inventory management, analytical testing execution and data release - Ensure that corrective and preventative actions are defined and implemented as a result of deviations occurred in the Area, and of internal and external audits - Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences - Assure the timely execution of the preventive maintenance program and execution of corrective maintenance. - 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.

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).

- Coordinate inbound and outbound logistical operations being accountable for the imports and exports of goods and also information flows supporting these operations; - Manage inventory, warehousing operations, regulate warehouse space, including reception, pathway, sampling, dispensing and arrange shipments, and local transportation to ensure an efficient supply of goods; - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks and suggesting process optimizations or improvements; - Ensure activities are carried out in compliance with cGMP, HSE, cGDP and all other required processes, legal requirements in the country of operation, complying with and enforcing all Hovione processes and good practice; - Dispense raw materials in line with Production requirements and assure it is done according to the procedures in place; - Monitor and control temperature and/or humidity for each storage location as required; - Perform the physical inventory checking according to the required schedule or procedure; - Ensure the correct identification and use of equipment (labels, plates, logbooks etc.); - Ensure correct and in full completion of documentation (e.g. record forms, logbooks); - Use computer programs correctly (including but not limited to email, SAP, LIMS and XNET).

- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures; - Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, and other GMP related documentation for all processes run in operations; - Participate and ensure, with supervision, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities; - Report, investigate and document any 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; - Report abnormal situations at the installations, as soon as these are detected, so that corrective maintenance is triggered in due time; - Takes lead on non-complex projects / campaigns (with guidance) and supports the lead process engineer in complex projects / campaigns; - Provide training on manufacturing processes to operational team members ensuring they are appropriately trained to perform the process related tasks; - Initiate and prepare, with supervision, tech-transfers and process improvement projects for established processes utilizing best available technology, practices and tools; - Contributes to the increase of productivity by reviewing and proposing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes.

- Contribute to the development of the Operational Excellence Roadmap to deliver the long term needs of the organisation by leading the establishment systems such as: - Tiered Performance Management in production and supporting functions. - Visual Management. - Root Cause Problem Solving. - Production Process Optimisation. - Standardised Work including Leaders Standard Work. - Lead the optimisation of Production, QC, Maintenance, and other supporting processes using fact-based analysis. - Identify the areas for improvement through data analysis and direct observation. - Identify the appropriate operational excellence tools to deliver and sustain these improvements. - Lead the implementation of these tools addressing the adoption of new ways of working by team members as well as the technical application of tools. - Play a leading role in the establishment of a culture and mindset of continuous improvement across the business. - Influence team members across all levels of the organisation to adopt a new ways of working. - Coach team members to develop their continuous improvement skills. - Implement the systems to reinforce a new way of working. - Synthesise detailed analysis for ease of communication across the organisation, from the production floor to senior leadership. - Participate in tiered performance management meetings in a coaching role - 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.

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.

To be responsible for the management of Process and/or Production works/projects assigned to the role on site. Active participation on new projects, technical transfers from other sites, development in scale up and process improvements to established processes.   Responsibilities:   - Implement all Process/Production related projects within area of work in compliance with all relevant legislation and regulatory standards including HSE and Quality, and in accordance with the Project Engineering department ways of work. - Participate in / lead technical transfer or process improvement projects for established process utilizing best available technology, practices and tool as appropriate at all times. These include the use of Lean Manufacturing Techniques, Risk Assessment Technology, Quality by Design, etc. - Ensure all project risk assessments are carried out in a compliant manner in line with established SOP’s and policies. - Responsible for preparation and review of /process engineering documentation including project plans and cost proposals, validation plans and execution of validation activities in relation to projects, preparation of validation reports, etc., correctly in a timely manner, while liaising with the Quality Department as required. - Responsible for on-time project delivery, projects delivery within budget, maintenance of validation status for all project related equipment to the required regulatory standards. - Investigate and document process/production and project related deviations, planned deviations, out of specification results and implementation of agreed corrective actions as appropriate. - Initiate, document, and process change controls for project process/engineering related matters as appropriate. - Present a written monthly report to the Manufacturing Director providing details on agreed KPI’s and metrics