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Independent compliance function within HSE focused on the development and implementation of an internal audit methodology to monitor and report on management system capability and effectiveness.  Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and assesses and reports on how requirements are being met. Supports regulatory audits and new license applications.   - Design and guarantee the implementation of an effective HSE Management System that is compliant with applicable regulatory requirements, company and site policies, operating procedures and standards. - Define and monitor compliance with the HSE Management System requirements in the assigned areas, producing accurate statistical records and preparing and presenting KPI and performance reports on a periodic basis, to site leadership and Corporate HSE. - Ensure an effective HSE documentation management system is in place and maintained in the assigned areas. - Ensure risk management procedures and systems are in place, monitoring and reporting on the effectiveness of these procedures and systems. - Manage the HSE Management System internal audit program in the assigned areas. - Maintain and manage effective relationships with Corporate, external authorities, regulators, and the community in relation to HSE matters under responsibility; managing data submissions, licensing and applications as required. - Oversee external audits, investigations and risk assessments as required, guaranteeing the prompt implementation of agreed upon recommended actions or corrective measures resultant from any audits or reports on the effectiveness of the HSE management and support systems in the assigned areas. - Represent the assigned HSE areas in internal site meetings and engage stakeholders and areas to build effective working relationships. - Keep abreast of new regulations and legal developments in the assigned fields of expertise, analyzing applicability to Hovione and advising of changes required as appropriate. - Develop and accumulate strong HSE technical expertise in the assigned areas, sharing knowledge within the site to support HSE awareness and encourage a culture of compliance. - Seek high performance standards for HSE in the assigned areas, identifying and driving opportunities for continuous HSE improvement. - Provide an example of professionalism and support the induction and training of new colleagues within the area. - Propose the definition of yearly plans and KPIs for the HSE assigned areas. - 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 HSE strategic objectives - 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. - 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.

- Ensure the maintenance, service, repair and troubleshoot of all equipment and installations (mechanical / electrical / instrumentation) on site is performed as per Standard Operating Procedures, Maintenance work instructions or engineering best practices; - Participate in risk assessment of work permits and control of their appropriate execution; - Actively participate in the implementation of continuous improvement initiative and lean tools within the area; - Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions; - Assist in the training of more junior members of the maintenance area in their area of expertise; - Ensure the correct completion of all required documentation, paper or system based, associated with own and area work; - Ensure proper tidiness and cleanliness of the maintained equipment and area as well as of his/her working area; - Collaborate in the analysis / investigation of irregularities or CAPAs pertaining to area; - Follow established procedures and processes, with the ability to interpret instructions, drawings and equipment technical documentation; - Resolve non-complex problems related to discipline, with more complex issues being referred to line manager or technical team member.

- Lead the development and implementation of the site R&D strategy including alignment with the site objectives and Global R&D - Responsibility for leading the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs for our Cork site - Promote the scientific excellence and innovation in the area and contribute with technical expertise to expand the Intellectual Property, product and technology portfolios. - Establish the main objectives for the area, aligning these with R&D and Hovione’s corporate strategy - Establish a clear site R&D strategy including resources, capital investment, new technologies etc in order to meet customer and business needs - Ensure the development of safe, efficient, scalable, timely and cost-effective processes of commercial interest to Hovione - Identify and assess new business opportunities, trends and market needs, in collaboration with commercial colleagues, and ensure the use of up to date / best technology, processes and work practices - Facilitate and manage a culture of innovation within the group focused upon creating new technology value and solving existing technical challenges in alignment with the global R&D strategy - Develop and manage metrics designed to monitor performance and improves efficiencies, quality and HSE culture within the area - Devise and coordinate the implementation of new procedures or the change of existing ones, according to ruling COPs, SOPs and IOPs - Represent the R&D area (or nominate delegates) on meetings with clients, external and internal audits and for Product/Project teams. - Ensure the information flows between the R&D areas, the several internal and external customers and stakeholders - Promote scientific activities (i.e. seminars, congress participations, innovation ideas, papers and publications), innovation and implementation of new methodologies within the R&D area - Manage the R&D team including recruitment, integration, training needs and performance management in accordance with the company's HR policies and ensuring the team is aligned and motivated towards achieving Hovione's goals. - 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's strategic objectives. - Prepare and propose the annual area budget for the annual site R&D budget. - 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)

As a member of the Assessment team, you will have a key role in the company’s business acquisition process by performing economic evaluations in close collaboration with all relevant technical areas of the Company, to build best-in-class business proposals to our clients. -  Provide timely, accurate and complete cost evaluations, covering all aspects of a business proposal for development or commercial programs/campaigns. - Interact with all relevant internal stakeholders – sales, technical areas across all sites involved in project execution, the project manager and the bid manager. - Fulfil the SLA (Service level Agreement), thus enabling Hovione to bid competitively, within the client's timeframe expectation. - Apply up-to-date costing standards that reflect ambitious operational performance targets, while monitoring actual performance evolution, creating healthy tensions in light of negative evolution trends. - Collaborate with PMs and site controllers to perform variance analysis exercises (actual vs budget) for programs and campaigns, that contribute to the continuous improvement of the costing methodologies used in the area. - Use consistently best practices to resolve issues in effective ways aligned with company objectives and values. Once established in the role, your contribution to the company will be shown by: - Demonstrating specific understanding of the costing processes, workflow and interdependencies of all areas supporting the business. - A good understanding of main unit operations at Hovione. - A display of solid technical knowledge on use of the available Toolbox. - Commitment to SLA and in-full deliverables to business partners and/or management. - Proactively proposing impactful improvements to the continuous development of the Area's performance (SLA and accuracy) to processes and existing toolbox, resulting in tangible improvements in both functionality and usability. - Consistently displaying an adequate level of autonomy to deal with complex cost evaluations on the day-to-day operations. Proactively escalating topics to senior members when appropriate to support decision. Interfacing effortlessly with peer-level technical areas across all Sites. - Executing cost evaluations for programs under development or in commercial phase, in both existent and future installations, that account for multimillion dollars revenue. - Understanding the materiality of multiple options in a VUCA environment.

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.

- Support and mentor production teams to optimize manufacturing processes, minimize downtime, and maximize productivity; - Identify and troubleshoot operational issues, related with equipment and drug product processes, implementing innovative solutions to improve efficiency and quality; - Monitor and analyze production data to ensure compliance with regulatory standards and quality control measures; - Participate in client visits, serving as a technical expert and providing insights into our operational processes; - Contribute to prepare and review 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; - Update the Line Managers and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs; - Provide training and guidance to team members to achieve production objectives and enhance their skills and knowledge; - Coordinate tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools; - Act as a technical expert on operational activities; - Train, coach and manage operational teams to ensure fidelity to standards developed by Hovione and encourage individual ownership towards reaching overall team goals.  

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.

- 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 scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios. - Perform project analytical tasks for complex projects: e.g., method development, method and specification creation; method transfer, protocols and reports preparation. - Solve complex project analytical problems - Determine scope of work and propose solutions that meet and exceed the Client’s expectations - Discuss actively with customers on technical and scientific issues - Prepare and discuss complex product specifications - Conduct and supervise analytical investigations and contribute in the definition and implementation of corrective actions - Support audits and client visits - Evaluate and approve materials, supplier/qualification - Master Analytical Chemistry processes and tools - Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

- 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).

The Warehouse & Logistics Specialist will be responsible to ensure all warehouse activities are carried out correctly and in efficient way following the cGMP/GDP, HSE rules and internal procedures. - Execute professional activities in compliance with GMP, GDP 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); - Verify that the quality policy is followed by the warehouse teams; - Maintain the departmental IOPs updated and their execution within the area; - Verify that stocks are under proper storage and control, conducting controls over goods; - Verify that required materials quantities for production and internal clients are provided as per schedule; - Implement new warehouse processes and methodologies according to guidelines; - Analyze warehouse and logistics data, producing reports relevant for area; - Contribute with proposals for the increase productivity and compliance; - Ability to gather data that is relevant for the decision making process in the area - Collaborate in the training of warehouse teams, proposing contents and delivering training sessions when required; - Follow customer and authorities audits and inspections and implement needed changes as requested. 

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.   - Evaluate the needs of both the material and human resources for the analytical projects to guarantee that the right analytical support is given in time to customers - Manage the proposals of alternatives to projects analytical packages - Support the implementation of new and state of the art analytical methodologies - Review and approve the analytical test methods to be executed in the laboratory and the protocols, reports and documentation prepared in the Area or provided by the customers - Ensure the information flow between the laboratory and the several internal and external customers - Support analytical development activities and investigations, providing guidance and technical analytical consultancy to teams across the organization, particularly in the problem solving process - Monitor the performance of the group, implementing the necessary measurements for continuous productivity increase - Promote scientific excellence and innovation within the team and support in the implementation of new technologies/methodologies - Contribute to the proposal of the Exploration and Investment budgets - 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 DEPARTMENT strategic objectives - 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 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.

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.

- 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.  

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).

- Organize and ensure the correct recording and treatment of accounting data and support the control of monthly tax obligations  - Support for the calculation and treatment of the company's tax issues  - Support for monitoring tax inspections by the Tax Authoriry  - Definition of methods and work processes in this area, as well as in the interconnection with the other areas of shared services and Treasury  - IFRS reporting support to the consolidation area  - Support for the monitoring of audit work and TAX consultancy   - Support for the supervising the entity's accounting and and preparing the respective financial statements  - Develop and maintain internal controls to support financial and accounting reports 

- Reviewing the profit and loss statement, balance sheet and cash flow statement of all subsidiaries on a monthly basis; - Analyzing all balances and transactions with related parties; - Preparing the consolidation file and ensuring all the consolidation adjustments are proper documented. - Preparing the report of consolidated financial statements to top management - Preparing the annual audited consolidated financial statements, liasing with external auditors - Identifying the key controls to be implemented in the organization - Discussing controls to be implemented in each area of the organization and the key users - Explaining non operational controls

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.   - Guarantee cGMP compliance within the area, by assuring that all necessary procedures are implemented on the site, according to the products requirements and as established in specific Quality and Technical Agreements - Manage teams and Team Members, ensuring the best organization of work to deliver on the key area objectives - Manage complex cGMP programs - Ensure the best structure, tools and prioritization to allow timely and quality release of products - Ensure that plans are in place to regularly inspect the operational areas to verify compliance with cGMPs - Lead clients and regulatory audits or inspections as required - Manage and evaluate regularly data regarding the Key performance indicators established for the area, ensuring actions are taken whenever there are deviations - Partner with the various areas to identify areas for improvement of how they work together - Support a continuous improvement mind-set within the area to simplify and streamline how things are done within the area - Assure that flexibility and simplicity are achieved through an entrepreneurship mind set and a “opt-in/opt-out” of procedures to meet the “fit for use” approach - Approve complex IOPs, change control documents (PdAs), process and equipment related documentation as required - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives - Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established production schedules while managing internal resources (people & equipment) and fulfilling customer requirements.   - Prepare all manufacturing plans for the production lines under their responsibility, managing resources allocation and assigning the members responsible (when applicable) for specific tasks - Establish the annual objectives for all their direct reports and follow up accordingly - Oversee the activities of his/her team, assuring that they have the right resources and the right knowledge to do their job and reach the defined objectives - Support the assessment workflow during projects business evaluation / technical introduction to the area - Develops areas of human expertise regarding manufacturing execution, in all its components (technical and soft skills) - Survey the working conditions of the facilities under their responsibility, making proposals for need of investment. - Revise and approve campaign related documentation, for projects conducted under the supervision of their group - Enforce fulfillment of the Good Manufacturing Practices (GMP) and HSEE policy, by conducting inspections and liaising with other Areas - Assure HSE operational program targets accomplishment - Coordinate and assure on time preventive maintenance program execution and effective / efficient corrective maintenance, for facilities under their responsibility - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with the area’s strategic objectives - Monitor Area´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures