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Packaging Engineer 80-100% (d / f / m)
Michael PageBasel, CHIl y a plus de 30 jours
Description de posteBachelor degree or higher in Engineering / Chemistry or equivalent combination of relevant education and applicable job experience 5-10 years of progressively responsible experience as packaging engineer for small molecules is an absolute must Strong technical understanding of the biopharmaceutical packaging process Extensive knowledge of current Good Manufacturing Practices (cGMPs) Contract service provider experience Demonstrated experience with preparing / reviewing annual product review / product quality review reports Able to operate effectively and with a strong sense of urgency in a fast-paced environment Good communicator : clear, concise, well organized and appropriate to the audience Business fluency in English, additionally German and / or French is a plus Domestic and International travel is required for this role Modern working environment with state-of-the-art facilities and technologies Challenging assignments in a fast growing and innovative industry Position in a dynamic, international team of highly skilled professionals Hybrid work option
The Packaging Engineer will be in charge of the coordination of packaging with commercial drug product Contract Manufacturing Organizations (CMO's), and other third-party suppliers for small molecule products :
The candidate will be responsible for the following tasks areas :
- SME for primary and secondary packaging (for small molecules)
- Develops and maintains good working relationships with contract manufacturers
- Coordinates periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items
- Maintains and follows through a consolidated Manufacturing action log to ensure all manufacturing related actions are completed on time.
- Prepares Annual Product Reports with Manufacturing CMOs according to company`s needs
- Works with CMOs and company`s participants to schedule and coordinate Steering Committee Meetings
- Works with Quality Group and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
- With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures
- Provides onsite process coverage as person-in-plant as needed
- Develops, collects appropriate internal and external metrics to measure CMO and company`s performance
- Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team
The successful candidate must have :