CSV/CSA Validation Engineer - On-Site in RDU Area

barrywehmiller; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Barry-Wehmiller Design Group is seeking a Computer Senior Validation Engineer to plan, develop, and execute computer system validation for manufacturing and automation systems in the Raleigh-Durham area. You will author validation plans, test cases, protocols, and reports, while coordinating with engineering, quality, and operations teams.

The role requires a strong foundation in CSV/CSA regulatory guidelines, risk-based validation approaches, and related life sciences or engineering experience.

Qualifications

• Expertise in Computer System Validation / Assurance, with hands-on protocol development
• 3-8 years of experience in a similar validation role in regulated industries
• Bachelor's degree in Engineering, Computer Science, Life Sciences or related field

Responsibilities

• Plan, develop, and execute computer system validation activities for manufacturing and automation systems
• Create validation plans, test cases, protocols, and reports; review requirements and design documents
• Collaborate with engineering, quality, and operations to maintain compliant documentation and processes

Skills

CSV/CSA expertise

Validation protocols

Experience 3-8 years

Engineering background

Regulatory knowledge FDA/GxP

Education

Bachelor's degree in Engineering/Computer Science/Life Sciences

Job description

Barry-Wehmiller Design Group is seeking a Computer Senior Validation Engineer to plan, develop, and execute computer system validation for manufacturing and automation systems in the Raleigh-Durham area. You will author validation plans, test cases, protocols, and reports, while coordinating with engineering, quality, and operations teams.

The role requires a strong foundation in CSV/CSA regulatory guidelines, risk-based validation approaches, and related life sciences or engineering experience.