Automation Validation Engineer II

BeiGene, Ltd.; Hopewell (VA); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k

Stock options

Bonus plan

Job summary

BeOne Medicines Ltd. seeks an experienced Automation Validation and CSV professional to support the facility.

The role focuses on developing and maintaining validation documents, leading validation activities for automated systems, and ensuring compliance with cGMP, data integrity, and regulatory requirements. You will collaborate across manufacturing, quality, and engineering, manage project documentation, and help meet KPIs such as cycle times and on-time closure.

Qualifications

• BS or higher in engineering and/or scientific discipline.
• Strong knowledge of cGMPs and data integrity principles.
• Experience with validation in FDA-regulated settings.
• Ability to lead validation projects and collaborate cross-functionally.

Responsibilities

• Develop and approve cGMP documents including automation qualification and validation plans.
• Lead validation activities for automated systems and equipment.
• Create and review validation protocols and reports; support audits and CAPAs.
• Collaborate with manufacturing, quality, and engineering teams.

Skills

cGMP knowledge

Data integrity

Risk assessment

Communication

Education

BS or higher in engineering/science

Tools

Microsoft Office

SAP

Job description

BeOne Medicines Ltd. seeks an experienced Automation Validation and CSV professional to support the facility.

The role focuses on developing and maintaining validation documents, leading validation activities for automated systems, and ensuring compliance with cGMP, data integrity, and regulatory requirements. You will collaborate across manufacturing, quality, and engineering, manage project documentation, and help meet KPIs such as cycle times and on-time closure.