Manufacturing Systems Engineer
BeiGene
Summary
As a key member of the site IT team at BeOne Medicines' Hopewell, NJ facility, the role focuses on supporting IT operations for manufacturing systems to ensure reliable systems, services, compliance, and optimizing business processes. Responsibilities include overseeing service delivery, customer support, maintaining stakeholder relationships, and driving operational excellence.
Job description
Technical & Operational Skills
- Expertise in Manufacturing Systems, backup, disaster recovery, and system security
- Strong understanding of manufacturing systems: Bioreactors, Filling Machine, and integrated Skids
- Familiarity with elogbooks, EBR, and MES
GxP & Compliance Expertise
- Knowledge of GxP regulations, particularly GMP and GAMP 5
- Experience collaborating with Quality, Validation, and Business Process Owners to ensure compliance in a GxP setting
- Skilled in handling internal and external audits, document preparation, conducting walkthroughs, and addressing observations
- Well-versed in validated system lifecycle activities: URS, IQ, OQ, SOP, change control, deviation management, and CAPA
Key Duties
- Maintain and troubleshoot essential manufacturing systems for uninterrupted operations
- Uphold IT quality compliance standards like GxP and FDA regulations; ensure audit readiness
- Lead incident management, system backups, restores, and proactive infrastructure maintenance
- Collaborate with cross-functional teams to ensure IT services meet business needs
- Initiate continuous improvements to enhance system performance and user experience
Requirements
- Bachelor's degree in information technology, Computer Science, engineering or related field
- 3+ years of progressive IT experience supporting Manufacturing systems
- Proven ability to support manufacturing and operations through reliable and compliant IT services
- Expertise in Manufacturing Systems, backup, disaster recovery, and system security
- Strong understanding of manufacturing systems: Bioreactors, Filling Machine, and integrated Skids
- Familiarity with elogbooks, EBR, and MES
- Knowledge of GxP regulations, particularly GMP and GAMP 5
- Experience collaborating with Quality, Validation, and Business Process Owners in a GxP setting
- Skilled in handling internal and external audits, document preparation, walkthroughs, and observations
- Well-versed in validated system lifecycle activities: URS, IQ, OQ, SOP, change control, deviation management, and CAPA
- Project Management experience
- Lean Six Sigma, Whitebelt training and experience
- Proficiency with Windows Server AD, MS-SQL, Smartsheet, Veeam, Veeva
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan
- Discretionary equity awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.