Senior Engineer I, Drug Product Process Engineer (Hopewell, NJ)

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

General Description:

BeOne Medicines is seeking a highly motivated and organized Drug Product Process Engineer to join our team at the Hopewell, NJ site. The successful candidate will be responsible for maintaining the Fill Finish line and providing engineering services to assigned projects and troubleshooting. This role works independently, with minimal supervision and direction and will provide technical direction, Project Management support, Commissioning and SME expertise in the areas of Facility, Utility and Metrology, instrumentation /control services. Projects may often require independent decision making and exercising judgment.

Responsibilities:

• Support of technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to drug product manufacturing.

• Partner with Operations, Quality, and Automation functional areas on validation studies in support of GMP process equipment (IQ/OQ/PQ), cleaning (CIP, COP), Sanitization and Sterilization (SIP, autoclave, depyrogenation, VHP).

• Develop and review technical documentation

• Participate and lead in controls fault analysis and remediation

• Directly support operations with troubleshooting and issue resolution

• Work on small cross functional teams in support of small projects or initiatives

• Requires working in an industrial manufacturing environment including gowning

• Support operations and ensure compliance with regulatory, corporate and site requirements

• The ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position. In addition, the ability for this person to develop and maintain transparent communication between departments is essential

Required Education/Experience:

• BS or higher in engineering and/or related discipline.

• Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or project management and at least 3 years of project management experience in biologics or GMP

• Minimum of 5+ years of GMP pharmaceutical operations support.

• Proven ability to manage multiple complex priorities simultaneously under tight timelines.

• Analytical problem-solving skills and proactive decision-making.

• Ability to summarize and present project information clearly to management.

• Prior hands-on experience in the design, selection, and troubleshooting of systems and equipment used in commercial drug product production is required. This includes experience working with Lyophilizers, isolators, aseptic/sterile filling machines, etc.

• Experience with production support equipment: parts washers, autoclaves, etc. is preferred.

Preferred Skills/Experience

• OE and/or LEAN Methodologies

Physical Requirements :

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas.

• May require up to 5% travel, including visits to partner or manufacturing sites.

• Must be able to sit, stand, and use standard office equipment for extended periods.

Computer Skills:

• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).

• Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.

• Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI).

• Ability to create and maintain Gantt charts, dashboards, and tracking templates.

• Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar).

Travel:

May require domestic travel up to 5% travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.