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Vor 2 Tagen
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:
- Bachelor 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
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