Senior Packaging Engineer (Hopewell, NJ)

About the role

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.

Responsibilities

• 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.

Requirements

• Bachelor’s degree and 4+ years of Engineering experience required.
• Master’s degree and 2+ years of Engineering experience preferred.

Qualifications

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

SkillsProficient in Microsoft Office applications (Word, Excel, and Outlook).

ERP Systems (SAP preferred).

Benefits

• Salary Range: $109,900.00 - $144,900.00 annually.
• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Opportunity to own shares of BeOne Medicines Ltd. stock.

Pay

$109,900.00 - $144,900.00 annually.

Schedule

Less than 10% travel.