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. Beginning 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 engineer serves as the site Packaging Subject Matter Expert and primary liaison with the Global Packaging Engineering & Artwork group, upholding company standards and packaging practices. The position provides technical support for packaging operations and works cross-functionally with site packaging, supply chain, commercial, regulatory, finance, quality, and other BeOne teams to commercialize products and create a successful patient experience. The role also manages Site Material Specifications and the Bill of Materials (BOM), and ensures packaging systems, equipment, and processes comply with global regulatory requirements.
Requirements
- Bachelor’s degree.
- At least 5 years of Engineering experience.
- Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
- 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.
Nice To Haves
- Master’s degree.
- At least 4 years of Engineering experience with a Master’s degree.
- Experience with ERP systems; SAP is preferred.
Responsibilities
- Provide life cycle validation technical support for the Hopewell site’s Oral Solid Dose packaging operation.
- Support Technology Transfer, equipment installation and start-up, and site readiness for Process Performance Qualification (PPQ) and Continued Process Verification (CPV).
- Serve as the site Packaging SME and primary liaison with the Global Packaging Engineering & Artwork group.
- Provide technical support for packaging operations and collaborate with cross-functional teams to commercialize products.
- Manage Site Material Specifications and the Bill of Materials (BOM).
- Ensure packaging systems, equipment, and processes comply with global regulatory requirements.
- 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 regulatory submissions and author regulatory documents for product applications or filing support.
- Lead complex investigations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPAs).
- Provide technical support for ongoing Hopewell packaging activities, including process troubleshooting and new equipment initiatives.
Benefits
- Annual bonus plan eligibility for non-commercial roles.
- Incentive compensation plan eligibility for commercial roles.
- Opportunity for all employees to receive discretionary equity awards and voluntarily participate in the Employee Stock Purchase Plan.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- FSA/HSA.
- Life insurance.
- Paid Time Off.
- Wellness benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
