Senior CSV Engineer — Manufacturing System Validation Expert

Barry-Wehmiller Companies Inc.; Raleigh (NC); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

First Year Experience program

Individual Development Plans

Career Path resources and tools

Job summary

Barry-Wehmiller Design Group in Raleigh-Durham-Chapel Hill is seeking a Computer Systems Validation Engineer to join a team of experts delivering compliant validation for manufacturing and automation systems.

You will plan and execute validation activities, develop plans, test cases, protocols and reports, review requirements, perform risk assessments, and collaborate with engineering, quality and operations to ensure regulatory standards are met.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences or a related technical field.
• 3–8 years of experience in computer system validation/assurance.
• Experience with validating manufacturing and automation systems; knowledge of CSV/CSA guidelines.

Responsibilities

• Plan, develop, and execute computer system validation activities for manufacturing and automation systems.
• Author validation plans, test cases, protocols, and reports.
• Review system requirements and design documents; perform risk assessments; ensure regulatory compliance.
• Collaborate with engineering, quality, and operations; maintain documentation; improve validation processes.

Skills

CSV/CSA regulatory guidelines

Test case development

Data integrity

Risk-based validation

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences or related field

Tools

Laboratory instruments

Bio process equipment

Job description

Barry-Wehmiller Design Group in Raleigh-Durham-Chapel Hill is seeking a Computer Systems Validation Engineer to join a team of experts delivering compliant validation for manufacturing and automation systems.

You will plan and execute validation activities, develop plans, test cases, protocols and reports, review requirements, perform risk assessments, and collaborate with engineering, quality and operations to ensure regulatory standards are met.