Manufacturing Systems Engineer

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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 Function:

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:
• 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
• 3+ years of progressive IT experience, supporting Manufacturing systems.
• Proven ability to support manufacturing and operations through reliable and compliant IT services.

Other Experience:

• Project Management, Lean Six Sigma, Whitebelt 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, MS-SQL, Smartsheet, Veeam, Veeva

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $102,200.00 - $132,200.00 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.

We are proud to be an equal opportunity employer. BeOne does 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 appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].