Drug Product Process Engineer — Fill/Finish GMP Expert

BeOne Medicines Ltd.; Pennington (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

BeOne Medicines Ltd. in Hopewell, NJ is seeking a Drug Product Process Engineer to maintain the Fill Finish line and provide engineering services across projects.

You will partner with Operations, Quality, and Automation, support technology transfer, qualification studies, and GMP validations, and lead troubleshooting and cross-functional initiatives. The role requires five years in biopharmaceutical manufacturing and hands-on experience with lyophilizers, isolators, and aseptic filling, with a

Qualifications

• BS or higher in engineering and/or related discipline.
• 5+ years in biopharma manufacturing, engineering, or PM.
• At least 3 years PM experience in biologics or GMP.
• 5+ years GMP pharmaceutical operations support.
• Proven ability to manage multiple complex priorities under tight timelines.
• Analytical problem-solving and proactive decision-making.
• Ability to present project information clearly to management.
• Hands-on experience with drug product equipment (lyophilizers, isolators, aseptic filling).
• Experience with production equipment (autoclaves, washers).

Responsibilities

• Support tech transfer and qualification studies for drug product processes.
• Partner with Operations, Quality, and Automation on GMP validation (IQ/OQ/PQ), CIP/COP, SIP, autoclave, depyrogenation, VHP.
• Develop and review technical documentation.
• Lead controls fault analysis and remediation.
• Support operations with troubleshooting and issue resolution.
• Work in cross-functional teams on small projects.
• Work in industrial manufacturing environment including gowning.
• Ensure compliance with regulatory, corporate and site requirements.
• Maintain clear communication across departments.

Skills

Analytical problem-solving

Proactive decision-making

Project management

Communication with management

Team collaboration

Gowning in manufacturing environments

Education

BS in Engineering

Tools

Lyophilizers

Isolators

Aseptic filling machines

Autoclaves

Parts washers

AutoCAD

Microsoft Project

Smartsheet

Power BI

Veeva Vault

Job description

BeOne Medicines Ltd. in Hopewell, NJ is seeking a Drug Product Process Engineer to maintain the Fill Finish line and provide engineering services across projects.

You will partner with Operations, Quality, and Automation, support technology transfer, qualification studies, and GMP validations, and lead troubleshooting and cross-functional initiatives. The role requires five years in biopharmaceutical manufacturing and hands-on experience with lyophilizers, isolators, and aseptic filling, with a