Senior Packaging Engineer

Responsibilities

• Serve as the site Packaging Subject Matter Expert (SME) and primary liaison for Global Packaging Engineering & Artwork.
• Provide technical support for Oral Solid Dose (OSD) packaging operations, including technology transfer, equipment installation, and start-up.
• Manage site-level Change Controls related to packaging components and artwork.
• Review and approve Packaging Batch Records as the technical owner.
• Author validation protocols, reports, and regulatory documents to support product applications.
• Lead complex investigations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPAs).
• Manage Site Material Specifications and the Bill of Materials (BOM).
• Ensure all packaging systems and processes comply with global regulatory requirements (FDA, EMA, etc.).

Requirements

• Bachelor’s degree in Engineering.
• 4+ years of professional Engineering experience.
• Proficiency in Microsoft Office applications (Word, Excel, and Outlook).
• Experience working with ERP systems (SAP preferred).
• Knowledge of GMP and GDP regulatory requirements.
• Demonstrated experience leading cross-functional teams or projects, preferably within the biotech or pharmaceutical industry.

Preferred Qualifications

• Master’s degree in Engineering with 2+ years of experience.
• Experience in technology transfer and process performance qualification (PPQ).

Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan.
• FSA/HSA options.
• Life insurance and wellness programs.
• Paid Time Off (PTO).
• Eligibility for discretionary equity awards and Employee Stock Purchase Plan.

About the Company

BeOne is a global oncology company dedicated to discovering and developing innovative, affordable, and accessible treatments for cancer patients worldwide. With a global team of over 11,000 colleagues, we are committed to improving patient access to life-saving medicines through bold ingenuity and a collaborative spirit.