Senior Manager Packaging Engineering

Responsibilities

• Lead commercial packaging qualification for drug substance, drug product, and primary container/closure systems at the Hopewell, NJ site.
• Serve as the technical packaging lead in cross-functional teams including supply chain, regulatory, quality, and clinical.
• Direct the design, qualification, and implementation of commercial packaging and thermal shipping solutions.
• Manage package development documentation, including technical drawings, specifications, and protocols using the Veeva system.
• Execute risk assessments, qualification plans, and summary reports related to component qualification and packaging line testing.
• Support product launches, tech transfers, and global expansion initiatives with specialized packaging expertise.
• Manage change controls and deviations related to packaging processes and equipment.
• Author regulatory documents in support of product applications and filings.

Requirements

• Bachelor’s degree with 7+ years of engineering experience, or a Master’s degree with 5+ years of engineering experience.
• Demonstrated experience leading teams, projects, or programs within the biotech or pharmaceutical industry.
• Strong knowledge of global pharmaceutical regulatory requirements, including GMP and GDP.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook) and ERP systems.
• Ability to travel up to 20%.

Preferred Qualifications

• Experience with Veeva systems for document management.
• Experience in thermal shipping system qualification and temperature-controlled logistics.

Benefits

• Competitive salary range: $141,600.00 - $186,600.00 annually.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan, FSA/HSA, and life insurance.
• Paid time off and wellness programs.
• Eligibility for discretionary equity awards and the Employee Stock Purchase Plan.
• Annual bonus plan eligibility for non-commercial roles.

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.