Automation Validation Engineer II – GMP/CSV Expert

BeiGene; Hopewell (NJ); On-site; USD 100,000 - 135,000; Full time

Job summary

BeOne Medicines Ltd. seeks an experienced Automation Validation and CSV professional to lead validation activities for automated manufacturing systems in a regulated biotech setting.

You will develop and review validation protocols, manage risk-based assessments, and ensure compliance with cGMP and data integrity requirements. In this site-based role, you will collaborate with manufacturing, quality, and engineering teams, oversee project planning, and drive on-time, on-budget delivery while

Qualifications

• BS or higher in engineering and/or scientific degree.
• Strong knowledge of cGMPs and data integrity.
• Knowledgeable in risk assessments and risk-based approaches.
• Biotech and/or sterile manufacturing knowledge is required.
• Minimum of 4 years’ validation experience (with Bachelor’s) or 3 years with a Master’s in FDA-regulated biotech/pharma.
• Proven leadership and strong communication skills.

Responsibilities

• Develop and review validation protocols and reports (Automation Qualification, FAT/SAT, IQ/OQ/PQ).
• Lead validation activities for automated manufacturing systems and related controls (PLC/HMI/SCADA/DCS).
• Create/test automated validation scripts and frameworks; ensure compliance with GxP and data integrity.
• Participate in design reviews, FAT/SAT, commissioning, qualification, and production deployment.
• Manage project planning, risk assessments, and documentation lifecycle (URS, protocols, reports).
• Collaborate with manufacturing, quality, and engineering teams to meet KPIs and budgets.
• Investigate deviations and ensure proper CAPA and investigations.

Skills

cGMP knowledge

Risk assessment

Data integrity

Leadership

Communication

Time management

Attention to detail

Self-motivation

SAP

CSV/Automation Validation

Education

BS or higher in engineering or scientific field

Biotech/sterile manufacturing knowledge

Tools

SAP

Job description

BeOne Medicines Ltd. seeks an experienced Automation Validation and CSV professional to lead validation activities for automated manufacturing systems in a regulated biotech setting.

You will develop and review validation protocols, manage risk-based assessments, and ensure compliance with cGMP and data integrity requirements. In this site-based role, you will collaborate with manufacturing, quality, and engineering teams, oversee project planning, and drive on-time, on-budget delivery while