Job Description
The Packaging Engineer plays a crucial role in coordinating packaging with commercial drug product Contract Manufacturing Organizations (CMOs) and other third-party suppliers for small molecule products.
This key position involves:
* Serving as Subject Matter Expert (SME) for primary and secondary packaging, specifically for small molecules
* Maintaining good working relationships with contract manufacturers
* Coordinating periodic CMO Manufacturing meetings, preparing minutes and tracking completion of action items
* Maintaining and following through on a consolidated Manufacturing action log to ensure all manufacturing-related actions are completed on time
* Preparing Annual Product Reports with Manufacturing CMOs according to the company's needs
* Working with CMOs and company participants to schedule and coordinate Steering Committee Meetings
* Collaborating with Quality Group and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure
* Ensuring CMOs remain current and compliant with all GMP-related requirements, guidelines, and procedures, in partnership with Quality Assurance
* Providing onsite process coverage as person-in-plant as needed
* Developing and collecting appropriate internal and external metrics to measure CMO and company performance
* Communicating manufacturing or technology-related issues and information to Manufacturing production team members, department stakeholders, and other project team members
Requirements
* Bachelor degree or higher in Engineering/Chemistry or an equivalent combination of relevant education and job experience
* 5-10 years of progressively responsible experience as a packaging engineer for small molecules is mandatory
* 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 communication skills: clear, concise, well organized, and appropriate to the audience
* Business fluency in English; additional proficiency in German and/or French is a plus
* Domestic and International travel is required for this role