The Packaging Engineer will be in charge of the coordination of packaging with commercial drug product Contract Manufacturing Organizations (CMOs), and other third-party suppliers for small molecule products:
The candidate will be responsible for the following task 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 the company’s needs
* Works with CMOs and company 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 and collects appropriate internal and external metrics to measure CMO and company 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's degree or higher in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience
* 5-10 years of progressively responsible experience as a 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)
* 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.
#J-18808-Ljbffr