Staff Packaging Engineer
About The Position
As part of the Manufacturing Science and Technology group, the Staff Packaging Engineer provides life cycle validation technical support for the Oral Solid Dose (OSD) packaging operation at BeOne’s Hopewell, New Jersey manufacturing site. Starting with Technology Transfer, the role supports equipment installation and start-up and ensures site readiness for Process Performance Qualification (PPQ) and Continued Process Verification (CPV). The position serves as the site Packaging Subject Matter Expert (SME) and primary liaison with the Global Packaging Engineering & Artwork group, upholding company standards and packaging practices. It provides technical support for packaging operations and collaborates across functions—including operations, supply chain, commercial, regulatory, finance, and quality—to commercialize products and support a successful patient experience. The role manages site material specifications and the Bill of Materials (BOM), and helps ensure packaging systems, equipment, and processes comply with global regulatory requirements such as FDA and EMA requirements. The position may require early morning or evening meetings due to the company’s global operations. Travel is less than 10%.
Requirements
- Bachelor’s degree and at least 5 years of Engineering experience.
- Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
- Experience with ERP systems.
- Familiarity with global pharmaceutical regulatory requirements, such as GMP and GDP.
- Demonstrated experience leading teams, projects, or programs, or directing resource allocation, preferably in the biotech, pharmaceutical, or CRO industry.
- Ability to attend early morning or evening meetings as required by the company’s global operations.
Nice To Haves
- Master’s degree and at least 4 years of Engineering experience preferred.
- Experience with SAP preferred.
Responsibilities
- Manage site-level Change Controls related to packaging components and artwork changes.
- Review and approve Packaging Batch Records as the technical owner.
- Support development of Technology Transfer plans; author validation protocols and reports; and develop and implement CPV programs.
- Support authoring of regulatory submissions and author regulatory documents for product applications or provide regulatory filing and submission support.
- Lead complex investigations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPAs).
- Provide technical support for ongoing packaging activities at the Hopewell site, including process troubleshooting and support for new equipment initiatives.
- Serve as the site Packaging SME and primary liaison with the Global Packaging Engineering & Artwork group.
- Manage site material specifications and the Bill of Materials (BOM).
- Support packaging operations and cross-functional teams involved in product commercialization.
- Ensure packaging systems, equipment, and processes comply with global regulatory requirements.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits
- Eligibility for discretionary equity awards
- Voluntary participation in the Employee Stock Purchase Plan
- Annual bonus plan eligibility for non-commercial roles; incentive compensation plan eligibility for commercial roles
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What This Job Offers
Job Type
Full-time
Career Level
Senior
