Automation Validation Engineer II (GMP/CSV)

BeOne Medicines Ltd.; Hopewell (NJ); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Paid Time Off

Wellness program

Job summary

BeOne Medicines Ltd. is seeking an experienced Validation professional to lead automation validation and CSV activities at a site-based facility.

You will develop and execute validation plans for automated systems, PLCs, SCADA, and related platforms, ensuring regulatory compliance and timely project delivery. The role requires strong knowledge of cGMP, risk-based validation, and data integrity, with hands-on expertise in QA/QC environments and collaboration across manufacturing, quality, and

Qualifications

• BS or higher in engineering and/or scientific field.
• Strong knowledge of cGMPs and data integrity principles.
• Experience in FDA-regulated biotech/pharma environments with progressive responsibility.
• Knowledge of risk-based validation approaches and CSV/Automation Validation preferred.

Responsibilities

• Lead validation activities for automated manufacturing systems and related equipment.
• Develop and maintain automated test scripts and validation protocols.
• Review and approve cGMP documents including qualification plans and SOPs.
• Ensure compliance with data integrity and electronic records requirements.
• Coordinate with manufacturing, quality, and engineering teams to meet KPIs and schedules.
• Manage validation resources and external consultants on large projects.

Skills

cGMP knowledge

Risk assessment

Biotech manufacturing

Sterile processing

Regulatory compliance

Education

BS in engineering or sciences

Tools

SAP

Microsoft Office

Job description

BeOne Medicines Ltd. is seeking an experienced Validation professional to lead automation validation and CSV activities at a site-based facility.

You will develop and execute validation plans for automated systems, PLCs, SCADA, and related platforms, ensuring regulatory compliance and timely project delivery. The role requires strong knowledge of cGMP, risk-based validation, and data integrity, with hands-on expertise in QA/QC environments and collaboration across manufacturing, quality, and