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
Salary Range: $109,900.00 - $149,900.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
