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

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.

Requirements

• BS or higher in engineering and/or related discipline.
• Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or project management.
• 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.
• The 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.
• Experience with production support equipment: parts washers, autoclaves, etc.

Qualifications

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

Benefits

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.

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.