Packaging Engineer 80-100% (d/f/m)

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