Senior Manufacturing Systems Engineer

Preferred Experience : Pharmaceutical/Biotech Industry

Location : Hopewell

General Description:

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. As part of the Global Technology Services (GTS) team, the candidate will focus on enhancing systems, processes, and infrastructure to support the company’s growth

Essential Functions:

Technical & Operational Skills

• Expertise in Manufacturing Systems and OT infrastructure, including backup, disaster recovery, and system security.

• Strong understanding of manufacturing systems: DCS, Bioreactors, Filling Machine, Packaging Line, 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:

• User Requirements (URS), Installation Qualification (IQ), Operational Qualification (OQ)

• Standard Operating Procedures (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.

Minimum Requirements – Education and Experience:

• Bachelor’s degree in information technology, Computer Science, engineering or related field

• 7+ years of progressive IT experience, supporting Manufacturing systems

Other Experience:

• Proven ability to support manufacturing and operations through reliable and compliant IT services.

• Project Management, Lean Six Sigma, Greenbelt training and experience

Supervisory Responsibilities:

• No direct reports

• Supervise contractors and project resources

Travel:

• Occasional visits to other BeOne sites, Vendor sites

Computer Skills:

• Proficiency with Windows Server AD, AWS, MS-SQL, Smartsheet, Veeam, Veeva.

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.