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

Drug Product Process Engineer – Hopewell, NJ BeOne Medicines is seeking a highly motivated and organized engineer to join our team at the Hopewell, NJ site. The successful candidate will maintain the Fill Finish line and provide engineering services to assigned projects and troubleshooting. Responsibilities Support technology transfer and qualification studies for drug product manufacturing processes, systems, and facilities. Partner with Operations, Quality, and Automation on validation studies for GMP process equipment (IQ/OQ/PQ), cleaning (CIP, COP), sanitization and sterilization (SIP, autoclave, depyrogenation, VHP). Develop and review technical documentation. Participate in and lead control fault analysis and remediation. Provide direct operational support with troubleshooting and issue resolution. Work on small cross‑functional teams for project initiatives. Operate within an industrial manufacturing environment, including gowning requirements. Ensure compliance with regulatory, corporate, and site requirements. Maintain transparent communication between departments. Qualifications BS or higher in engineering or related discipline. Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or project management, with at least 3 years of project management experience in biologics or GMP. At least 5 years of GMP pharmaceutical operations support. Proven ability to manage multiple complex priorities under tight timelines. Analytical problem‑solving and proactive decision‑making skills. Clear presentation of project information to management. Hands‑on experience in design, selection, and troubleshooting of systems and equipment for commercial drug product production (e.g., lyophilizers, isolators, aseptic/sterile filling machines). Experience with production support equipment such as parts washers and autoclaves (preferred). Knowledge of OE and/or LEAN methodologies (preferred). Physical & Travel Requirements Work in office, construction, laboratory, or manufacturing areas, including gowning. May require up to 5% domestic travel, including visits to partner or manufacturing sites. Must be able to sit, stand, and use standard office equipment for extended periods. Technical 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). Salary & Benefits Salary Range: $109,900 – $149,900 annually. BeOne is committed to fair and equitable compensation practices. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and voluntary Employee Stock Purchase Plan. Equal Employment Opportunity BeOne is proud to be an equal‑opportunity employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by law. All employment is decided on qualifications, merit, and business need. Applicants requiring reasonable accommodation in the application process may contact View email address on click.appcast.io. #J-18808-Ljbffr