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.).
Essential Functions of the Job: - 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.
Education and Experience Required:- Bachelor's degree and 4+ years of Engineering experience required
- Master's degree and 2+ years of Engineering experience preferred
Supervisory Responsibilities: - No direct reports but will lead cross-functional teams.
Computer Skills: Proficient in Microsoft Office applications (Word, Excel, and Outlook), ERP Systems, (SAP preferred)
Other Qualifications:- 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.
Travel: Less than 10%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $109,900.00 - $144,900.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
