Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
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.
- Coordinate the implementation of new procedures or the change of existing ones, according to ruling COPs and SOPs.
- Enforce fulfillment of the GMP and HSE policy, by supporting inspections and liaising with other Areas.
- Ensure HSE operational program targets accomplishment.
- 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.
- 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 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.
- Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operation and high quality performance.
- Survey the working conditions of the facilities under the area responsibility, making proposals for need of investment and coordinating the implementation of the necessary actions to ensure a robust and reliable operation.
- Report abnormal situations at the installations, as soon as these are detected, so that corrective maintenance is triggered in due time.
- Identify and coordinate the implementation of corrective and preventive actions, looking at keeping the installation in good conditions.
- Coordinate and ensure on time preventive maintenance program execution and effective / efficient corrective maintenance, for facilities under the area’s responsibility.
- 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.
- Update the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs and on business.
- 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.
- 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.
- Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment.
- Act as Area representative during the design of new facilities or modification of existing ones, ensuring that critical operational aspects are properly accounted.
- Approve changes to facilities and/or equipment trains, when delegated by n+1.
- Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge and act as backup for n+1 technical tasks when required.
- 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.
- Develop areas of human expertise regarding manufacturing execution, in all its components (technical and soft skills);
- 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 practices that have the opportunity to optimize the manufacturing processes.
- Develop and maintain process optimization practices through implementation of simulation tools, data mining, or similar methods.
- Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects.
- Implement the actions derived from approved Area budgets, contributing to costs control and to the achievement of P&L targets.
- Prepare and propose annual budgets (third party expenses; CapEx) for production lines under the area’s responsibility.
- 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.
- Degree in a field of Science or Engineering (with a preference in Chemical Engineering)
- Experience working within the pharmaceutical industry in Pharmaceutical Fine Chemistry and/or Particle Engineering and/or Drug Product (areas of development, scale-up and production) (mandatory)
- Training and experience in GMP and HSE practices (mandatory)
- Experience in equipment and technology design (mandatory)
- Experience in technical manufacturing support
- Experience of technical transfer and capital project support
- Experience of multiple projects and product from early stage development to commercial scale
- Strong interpersonal skills to enable effective interactions with stakeholders (written and verbal)
- Competent (written and verbal) English
- Computer literate with good working knowledge of the MS Office package and SAP
- Advanced knowledge in organic chemistry and/or particle engineering technologies
- Advanced knowledge in scale-up of chemical engineering operations and/or drug product
- Expertise or significant experience in other departments or areas in a Pharmaceutical organization such as Quality Assurance, Analytical Development, Quality Control, Project Management, Process R&D, from completed assignments or past job experience (preferable)
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
Hovione is a proud Equal Opportunity Employer
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
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