Senior Packaging Engineer; Hopewell, NJ

As part of the Manufacturing Science and Technology (MST) group, the Senior Packaging Engineer will provide life cycle validation technical support for the Oral Solid Dose (OSD) packaging operation in the Hopewell, NJ manufacturing site. Starting with Technology Transfer, this position will support equipment installation and start-up and ensure site readiness for Process Performance Qualification (PPQ) as well as Continued Process Verification (CPV).

• Serve as the site Packaging SME and primary Liaison with the Global Packaging Engineering & Artwork group, to uphold company standards and packaging practices.

• Providing technical support for packaging operations, collaborating cross-functionally with operations, quality technical packaging lead in cross-functional teams including packaging site, supply chain, commercial, regulatory, finance, quality as well as across BeOne to commercialize products that create a successful patient experience.

• Manage Site Material Specifications and the Bill of Materials (BOM).

• Ensure all packaging systems, equipment and processes comply with global regulatory requirements (e.g., FDA, EMA, etc.).

• Manage site-level Change Controls in alignment with packaging components and artwork changes.

• Review and approve Packaging Batch Records as technical owner.

• Support development of Technology Transfer plan, and author Validation Protocols and Reports, and develop and implement CPV programs.

• Support authoring for Regulatory Submissions.

• Lead complex investigations, perform root cause analysis and implement Corrective and Preventive Actions (CAPAs)

• Technical support for ongoing packaging activities at the Hopewell site, including process troubleshooting and support for new equipment initiatives.

• Author regulatory documents in support of product applications or provide regulatory filing and submission support.

• Bachelor’s degree and 4+ years of Engineering experience required

• Master’s degree and 2+ years of Engineering experience preferred

• No direct reports but will lead cross-functional teams.

Proficient in Microsoft Office applications (Word, Excel, and Outlook), ERP Systems, (SAP preferred)

• Familiarity with global pharmaceutical regulatory requirements (e.g. GMP, GDP).

• Due to global nature of company early morning or evening meetings may be required.

• Demonstrated experience leading teams, projects, programs or directing the allocation of resources preferably within the biotech, pharmaceutical, CRO, industry.

Less than 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.