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Delivers excellence in end-to-end process improvement practices, methodologies, and behaviors to achieve transversally operational and support services areas’ efficiencies. Supports the continuous improvement cycle aiming at the sustainable increase of unitary output (effective throughput per resource unit used). Participation in the development, deployment, and maintenance of the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviors to enable engagement; as well as for deriving metrics to measure plant and equipment capacity to support identification of equipment and process flow bottlenecks, contributing to improved layouts whilst assuring compliance with established guidelines.   - Develop and apply knowledge of process optimization and participate in area processes, procedures optimization projects with the guidance of more senior colleagues - Take part in Continuous Improvement Initiatives, problem solving and risk assessment groups - Ensure that all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

- Create shift detailed schedule (short & mid-term) for the whole portfolio to answer demand, having into account production and support areas constraints (Quality Control, Warehouse, etc.) - Review and analyze the allocated resources (human resources, materials and/or processes) to comply with plan - Optimize the plan, ensuring the existence of resources for the continuous production and maximizing efficiency - 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 Site scheduling meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies - 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 - Make quality and timely decisions within the operations planning and data management tasks - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations  

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To maintain good hygiene and housekeeping within the laboratory. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - Comply with the high standards in the QC Laboratories. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Assist with audits as required, following the instruction of QC Management. - Undertake any additional tasks to support the laboratory activities as and when required. - Seek out additional information when one feels that the available information is not enough. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To maintain good hygiene and housekeeping within the laboratory. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - Be the go-to person for troubleshooting activities. - Drive high standards in the QC Laboratories. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - To propose corrective actions and suggestions for improvements. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Assist with audits as required, following the instruction of QC Management. - Undertake any additional tasks to support the laboratory activities as and when required. - Participate, as required, in the induction and training of new Analysts across Hovione. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.

Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.   - Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed - Assure that systems/processes/methods are qualified/validated according to their intended use and product requirements - Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities - Support Quality and Operational areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures   - Participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites, as requested by Corporate function  - Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance  - Participate in Conceptual, Basic and Detailed Design Review for Projects of each Hovione Site, and major Projects at any Site for Corporate function, in order to assure GMP compliance with applicable Guidelines, Corporate Procedures and any specific Site requirements   - Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team - Establishes the required qualification activities of new or changed systems and/or facilities within the change control process  - Prepare VMPs for Projects of each Site, collaborate in the VMP for major Projects and support Project’s execution at each site, for Corporate functions - Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic - Review Reports, at Site level Participate in the management of Quality Systems key activities  - Prepare/review Quality Systems methodologies related to the area objectives and provide training for the sites  - Propose qualification/validation related procedures and documents to be followed - Participates or support internal or external/customer audits and health authority inspections - Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility  - Propose improvements to the area as appropriate and solve problems  - Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility  - Gather relevant data to inform the decision makers regarding complex issues  - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) 

We are looking for an Editor, with a good sense of what makes an interesting angle to a narrative to support our internal and external content strategy. You will plan, write, review and edit content. The successful candidate will be able to make suggestion of approaches that address the business needs and meet quality and accuracy standards. The goal is to provide exceptional, informative and engaging content for both internal and external communications. - Set publication standards and establish goals and expectations. - Suggest and create content and generate headline ideas in alignment -company objectives for internal and external stakeholders. - Oversee final result in terms of layout (artwork, design, photography) and check content for accuracy and errors. - Write, Proofread, edit or improve stories or pieces. - Comply with ethical guidelines. - Meet deadlines and budget requirements. - Ensure that documents comply with Hovione's style guide and meet regulatory requirements. - Collaborate with authors and subject matter experts to ensure accuracy and clarity of documents. - Work closely with project teams to meet project timelines. - Manage document workflow and tracking. - Assist with training and mentoring the organization in best practices.

- Maintain and regularly update a pricing history database, putting the right process and systems in place to systematically capture this information about price Vs assessed cost for each bid signed. - Perform financial evaluation to assess pricing action effectiveness (pricing consistency studies) - Analyse financial impact of price approach in view of overall history as well as profitability of customer - - Assist with pricing negotiations of customers’ proposals - Support the prepare (and validation) of the Best and Final Offer (BAFO) - Manage total pricing procedure, enhance processes to make most of efficiencies and ensure timely response to market conditions.   - Lead and direct pricing strategy formulation and take necessary pricing actions to enhance profitability, ensuring integrity and accuracy in all pricing matters. - Track market trends and keeping up to date on prices set by competitors - Conduct oral presentations, field research and cost revisions. This also requires thinking about the going rates for similar products in the industry, in order to remain competitive.   - Make quality and timely decisions based on multiple sources of data - Manage risk and uncertainty; anticipate and escalate roadblocks 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).

• Actively engage and provide professional support to project teams in the areas of Project Controls; • Contribute as SME to the development of governance, processes, and training materials related to Engineering Controls; • Where appropriate, supports project reviews in the Engineering Controls field, to ensure that large projects follow and apply the Engineering Controls related guidelines; • Prepare schedule progress reports, trending charts and schedule analysis; • Assist with review and development, issuance and evaluation of subcontract change orders as required for their project tracking; • Consults with clients, vendors, or other individuals to discuss and formulate estimates and resolve issues; • Define the work scope and prepare overall schedules and budgets on various sized projects. Assists in developing requirements for budgeting standards; • Develops and implements requirements for cost recording, reporting, and analyzing standards, programs, and reports; • Develops required jobhour expenditure for assigned disciplines or specialties. Assists in determining leveling decisions. Performs quantity and manpower resource loading for assigned schedules; • Maintain and control budgets from design concept through to project completion; • Develops and monitors short term (2-4 week) engineering, procurement, construction schedules; • Monitors schedule deviation for assigned disciplines or specialties including subcontractor submittals and recommends corrective action/workaround solutions for project considerations; • Identify and evaluate potential changes and review of contractor invoices; • Coordinate implementation plan with project site teams and escalate areas of misalignment and improvement; • Examine requests for budget revisions, recommend approval or denial and draft correspondence; • Present results of cost analysis to Program Director & CAPEX committee; • Ensure alignment with the client's portfolio controls governance and objectives; • Assist with update to projections on cash flows, staffing plans and contingency usage; • Support the change control process, establishing the necessary forms, logs and expediting methods; • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice; • Undertake any additional tasks commensurate with the role as and when required.

Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.   - Actively contributes to the development and implementation of Hovione’s strategy for the area and the standardization of best practices - Supervise projects within the area, proving technical expertise and best practices to the area TMs and ensuring the right networks are developed, internally and externally - Assess potential future activities from a scientific perspective and estimate the resources required, including costs estimation - Review complex projects within the area to promote innovative approaches that can lead to the generation of IP (patents or trade secrets) - Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about Hovione technical competencies and capabilities - Ensure there is a continuous improvement mindset in the project implementation to enhance productivity, decrease costs and deliver the best service to our customers - Speak at Scientific Events and represent the company in international scientific forums - Address gaps in technical competencies by coaching and developing team members with the area - Lead multiple work fronts and ensure the implementation of best practice improvements within the area - Show business acumen, see the big picture and understand the impact of decisions on the business - Is regarded as a Subject Matter Expert within the company - 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 procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.   - Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed - Assure that systems/processes/methods are qualified/validated according to their intended use and product requirements - Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities - Support Quality and Operational areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures   - Participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites, as requested by Corporate function  - Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance  - Participate in Conceptual, Basic and Detailed Design Review for Projects of each Hovione Site, and major Projects at any Site for Corporate function, in order to assure GMP compliance with applicable Guidelines, Corporate Procedures and any specific Site requirements   - Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team - Establishes the required qualification activities of new or changed systems and/or facilities within the change control process  - Prepare VMPs for Projects of each Site, collaborate in the VMP for major Projects and support Project’s execution at each site, for Corporate functions - Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic - Review Reports, at Site level Participate in the management of Quality Systems key activities  - Prepare/review Quality Systems methodologies related to the area objectives and provide training for the sites  - Propose qualification/validation related procedures and documents to be followed - Participates or support internal or external/customer audits and health authority inspections - Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility  - Propose improvements to the area as appropriate and solve problems  - Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility  - Gather relevant data to inform the decision makers regarding complex issues  - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) 

Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers and influencers at an assigned group of customer accounts that may include major strategic customers within a geographic or industry focus. Identifies, develops and typically closes new sales opportunities. Creates demand for the organization’s products and services by raising their profile with customers. Achieves revenue targets by increasing revenue spend per account. Negotiates, with autonomy, highly complex and long term contracts. May conduct regular status and strategy meetings with the customer’s senior management to understand their needs and link them to the organization's product/ service strategies.   - Achieve the sales targets and ensure project deliver for the portfolio of customer accounts under responsibility - Manage the client interface of assigned accounts and provide outstanding commercial service through fast, trustworthy and knowledgeable responses to customer demands - Establish relationships with colleagues in different countries and job functions to ensure customer needs are met - Create and execute account management and development plans for the accounts under responsibility - Participate in negotiations of CDAs, Master Service Agreements and Commercial Supply Agreements for allocated accounts in close collaboration with the Senior Director of the area - Coordinate with the global regulatory, production, and R&D groups to provide a superior level of customer service and technical support - Develop and accumulate strong Hovione product and service expertise, sharing knowledge of offerings and cross-selling as appropriate - Analyse data, including demand forecasting, within Hovione´s Customer Relationship Management system for Europe to ensure accurate forecasting and reporting - Assist in the negotiation of long-term contracts including (but not limited to) sales contracts, quality agreements and development agreements - Identify market trends and demands and proposing ideas for new products and services - Identify new opportunities for the existing product and / or services portfolio and linking with the Business Development team as appropriate - Monitor customer account and market activity and provide concise and insightful analysis on customer dynamics, market developments and competitor activity - Optimize the relationship with established clients through both strategic and tactical means including (but not limited to) Key Account Plans, Account Growth Plans, Periodic Business Reviews, client visits and Satisfaction Survey Action Plans - Develop, issue and monitor account growth plans for allocated accounts - Prepare reports and data analytics - Attend and represent Hovione at Trade Shows - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with Sales strategic objectives - Monitor own´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

Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.   - Resolve a wide range of technical aspects within multiple projects in order to reach the established targets - Execute the projects according to the agreed work plan, selecting methods and techniques for obtaining the best solutions - Give Technical Support to projects of the group not directly under own responsibility - Present recommendations and builds on other’s ideas - Generate technical documentation - Contribute to the improvement of processes and procedures - Communicate with clients on and other parties on project related topics - Recommend methods and procedures on new or special assignments - Develop new procedures and methodologies based upon experience and innovative approach - Generate Intellectual Property and promote scientific activities & innovation - Develop own and others’ competences - Represent Hovione in external events, conferences, etc. - Train staff in subjects related to own area specifics/expertise - Participate in inspections and internal and external audits - Network with peers internal and external outside own area of expertise - Participate and lead peer reviews in own cross-functional teams and asset groups - 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 Scientist’s 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 - Responsibility over inhaler device portfolio development: from conceptual design to manufacturing - Create and evaluate device designs during the complete product life cycle, from conceptual level and IP generation, to detailed design and through manufacturing - Drive the device product development based on solid engineering principles, knowledge of materials, manufacturing processes, finishing and assembly to develop functional, performant, cost-effective and robust device designs and finding trade-offs in the complex design space of a drug-device combination product - Lead device verification testing through the product life cycle, identifying methods to test the designs, analyse the results and implement design changes based on these - Technical lead for new technology implementation in device filling & assembly - Prepare high-quality technical reports and documentation for supporting the Design History File

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities. - Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures. - Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations. - Execute and ensure, with autonomy, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities. - Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures. - Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate. - Participate in all necessary training as defined in the training plan. - Report abnormal situations at the installations, as soon as these are detected so that corrective maintenance is triggered in due time. - Identify the necessary corrective and preventive actions to keep, in a proactive manner, the installation in good conditions. - Act as the lead process engineer in multiple projects with limited support and liaises directly with customer project teams. - Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs. - Provide training on manufacturing processes, production systems and procedures to operational team members - Participate, as required, in the induction of new colleagues ensuring they are appropriately trained in accordance with established training plans. - Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operating and high quality performance. - Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable) - Assist with audits and investigations. - Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment. - Contribute to the design of new facilities or to the modification of existing ones. - Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge. - Develop and accumulate strong engineering expertise, sharing knowledge of state-of-the-art technologies and methodologies within the area. - Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools. - Contributes to the increase of productivity by reviewing, proposing, planning and implementing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes. - Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects. - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

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.   - Participate in the day to day preventative and corrective tasks (mechanical / electrical / instrumentation) in-line with the planned asset lifecycle management instructions - Maintain, service, repair and troubleshoot all equipment and installations (mechanical / electrical / instrumentation) on site as per Standard Operating - Procedures, maintenance work instructions or engineering best practices - Ensure that equipment and infrastructures are maintained within their safe design operating limits, and in a way that avoids danger to personnel or the public - Ensure the correct completion of all required documentation, paper or system based, associated with own work - Participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D) - Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA) - Ensure proper tidiness and cleanliness of the maintained equipment and area as well as his/her working space - Ensure that area or his/her assign tools are kept in good shape in what regards to their functionality and cleanliness - Participate in programs and initiatives required to ensure plant cleanliness - Follow procedures with clear instructions; seeks clarification if they are not clear - Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes - Suggest and participate in improvements in the area in which the TM is assigned - 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 practices - Undertake any additional tasks commensurate with the role as and when required

Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.   - Prepare complex and new submissions and manage submissions of existing products throughout the product lifecycle, in current and new markets - Execute complex pre and post approval compliance activities aligned with the company strategic plan and compliant with standard operation procedures and support less experienced colleagues - Submit applicable reports and ensure appropriate responses are submitted to regulatory authorities, monitoring the responses and supporting less experienced colleagues - Promote the importance of regulatory compliance throughout product lifecycle with other areas, working with them on complex and multifaceted issues - Provide training on regulatory matters to different areas of the company - Perform complex regulatory services as part of the CMO activities - Participate in inspections / audits, answering questions related to regulatory affairs - Lead shared services compliance activities, supporting less experience colleagues in resolving complex issues - Prepare and ensure that site licenses registration and product import licenses are kept updated - Compile, prepare and review updated regulatory filings to regulatory authorities - Assess and monitor changes, and their impact in the regulatory filings - Prepare and submit complex reports and responses to regulatory authorities - Propose updated strategies upon regulatory changes - Participate in Customer product submissions as part of CMO services (preparation and / or revision of DMF / NDA CTD sections, as contracted by the Customer and assist in the reply to the competent authorities on complex matters) - Verify that the regulatory requirements are followed in the preparation and updating of Hovione or Customer Product Files - Provide complex regulatory technical support to customers (management of requests, preparation of communications and technical packages for customers, coordination of document attestation/legalization, preparation of periodic reports) and support less experienced colleagues in the same - Search and select regularly updated information on legislation, regulations and guidelines, updating the internal processes and sharing information with the wider team - Discuss and provide technical guidance on complex regulatory requirements to other areas - Prepare complex reports and regulatory agency communications - Review and propose improvements to the annual assessment for the submitted filings - Review and prepare complex updated regulatory filings to authorities: amendments / updates / changes / variations, annual reports, responses to deficiency letters or requests for additional information - Actively participate in professional associations, industry/ trade groups (local/regional/ international) and appropriate standards organizations - Manage regulatory affairs databases and tracking systems - Review and propose improvements to regulatory affairs internal procedures - Master Regulatory Affairs processes and tools - Manage complex projects/ analysis with significant impact on business - Make quality and timely decisions based on multiple sources of data - Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

- Conceive, design and implement engineering solutions on the specific areas of engineering projects, towards a successful project conclusion, in order to achieve the company established objectives; - Prepare, revise and approve technical documentation of Engineering Projects, for conceptual, basic and detailed design phases; - Ensure that project documents are complete and optimal for a competitive tender process; - Prepare the project budget & timeline, and control them during execution; - Supervise the construction, installation, commissioning and qualification of assigned projects, within is area of responsibility; - Support the internal and external Engineering teams, integrating the work with other specialties into the final project solution, assuring user deadlines are met and without unexpected delays in production; - Work with the other Engineering areas and project management to resolve project issues, ensuring the delivery/completion of the project work; - Capture user feedback and lessons learned for future projects; - Propose improvements (procedures, organizational, new technologies, capex, productivity) in Engineering as appropriate; - Make quality and timely decisions within the Design Engineering tasks under his/her responsibility; - Create and select the technical documentation to be used as a learning tool for new engineers, a reference for future projects and a historical repertoire (e.g., for assessments and investigations).

- Design, project coordinarion and execution/qualification of strategic projects across all sites as part of the Global Engineering team; - Performs automation and qualification activities on facilities, equipment and utility systems, according to regulatory demands (cGMP, GAMP, FDA requirements, etc), industry applicable guidelines and internal procedures; - Planning, executing and supervising new or business continuity projects (MS Project, Meeting project deadlines and operation targets, milestones); - Prepare Project Budgets and Coordinate outside contractors working on facility projects; - Proactively develop, maintain, drive and communicate project timelines to broader cross-functional team on a weekly basis.

Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.   - Manage projects in the allocated area and escalate complex issues to more senior colleagues or managers. It is recognized that the level of support required will increase when projects that are more complex are assigned. Project assignment will always be based on business need, however, preferentially, projects assigned will have a low to medium degree of complexity including: - a low to medium cumulative sales / project cost value - a low to medium to high project control level - up to a medium customer segmentation level - Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned - Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or Company best practices - Lead the project team to take decisions or to decide to escalate the decision based on data - Contribute to the project team composition and selection - Clarify project team roles and responsibilities - Communicate proactively and effectively internally and externally - Build and sustain motivation of the project TMs and positive dynamics within the project team - Give timely and specific feedback to the project TMs regularly, both positive and constructive - Keep up to date on the best PM practices, standards and methodology in use within the industry - Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the project management tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.   - Actively contributes to the development and implementation of Hovione’s strategy for the area and the standardization of best practices - Supervise projects within the area, proving technical expertise and best practices to the area TMs and ensuring the right networks are developed, internally and externally - Assess potential future activities from a scientific perspective and estimate the resources required, including costs estimation - Review complex projects within the area to promote innovative approaches that can lead to the generation of IP (patents or trade secrets) - Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about Hovione technical competencies and capabilities - Ensure there is a continuous improvement mindset in the project implementation to enhance productivity, decrease costs and deliver the best service to our customers - Speak at Scientific Events and represent the company in international scientific forums - Address gaps in technical competencies by coaching and developing team members with the area - Lead multiple work fronts and ensure the implementation of best practice improvements within the area - Show business acumen, see the big picture and understand the impact of decisions on the business - Is regarded as a Subject Matter Expert within the company - 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

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.   - Corporate function responsibilities include definition of best practices and standards in partnership with sites and areas - Aligned with best practices and Corporate standards -Guarantee the execution of the supply chain activities under responsibility (transportation, warehouse management, import/export, distribution and/or planning), with a long-term perspective and finding creative solutions -Propose tactics to solve supply chain challenges, acting as a partner of production, maintenance, R&D and engineering - Establish relationships with suppliers and customers to improve supply chain operations in terms of effectiveness, guaranteeing client satisfaction and timely delivery -Oversee supply chain projects, giving direction and coordinating activities, in order to improve processes and systems -Propose and guarantee the implementation of inventory targets and purchases of goods -Create and implement supply chain metrics and KPIs ensuring its monitoring and control -Define and guarantee the implementation of revisions on the supply chain methodologies and processes used, guaranteeing an increased efficiency (transportation, warehouse management, import/export, distribution and/or planning) - Provide guidance in supply chain topics, keeping a good knowledge of processes, tools, legislation and methodologies (planning, scheduling, master data, warehouse management, import/export, transportation, distribution, etc.) - 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 Supply Chain strategic objectives  - Monitor own´s budget, by controlling budget 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