Job description
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.- 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) and in compliance with cGMP, HSE regulations and internal policies and procedures.
- Responsible for the accurately and timely preparation, review and approval of manufacturing process documentation 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.
- Identify and coordinate the implementation of corrective and preventive actions, looking at keeping the installation in good conditions.
- Act autonomously as the lead process engineer in multiple projects of high-complexity and/or with significant impact on business and liaises directly with customer project team, promoting active and transparent communication, including in complex situations.
- Provide training on manufacturing processes, production systems and procedures to operational team members.
- Support internal stakeholders on, including but not limited to, generation of project budgets 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.
- 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.
- 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.
We are looking to recruit a Candidate::
- Degree in a field of Science or Engineering (with a preference in Chemical Engineering)
- Relevant 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)
- Training and experience in GMP and HSE practices
- Experience in technical manufacturing support
- Experience of technical transfer and capital project support
- Strong interpersonal skills to enable effective interactions with stakeholders (written and verbal)
- Advanced knowledge in scale-up of chemical engineering operations and/or drug product
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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