GxP CSV Engineer: Validate Regulated Systems

Validation & Engineering Group, Inc.; Wilson (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Computer System Validation (CSV) Specialist/Engineer to support validation activities for computerized systems in a regulated manufacturing environment.

The ideal candidate has 3–4 years of hands-on CSV experience and solid understanding of GxP, lifecycle documentation, and data integrity. Responsibilities include developing validation documentation, performing testing, and ensuring compliance with 21 CFR Part 11.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, IT, Life Sciences, or related.
• 3–4 years of CSV experience in a regulated environment (pharma/biotech/medical devices).
• Working knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles.
• Experience developing and executing validation documentation and testing.
• Strong documentation, analytical and problem-solving skills.
• Ability to work cross-functionally with technical and quality teams.
• Strong written and verbal communication skills.

Responsibilities

• Support the validation and lifecycle management of GxP computerized systems.
• Develop, review, and execute validation docs: URS, FDS, risk assessments, plans, IQ/OQ/PQ, test scripts, traceability matrices, summaries.
• Execute and document system testing and resolve discrepancies and deviations.
• Support system implementation, upgrades, enhancements, and periodic reviews.
• Perform computerized system risk assessments per regulatory requirements.
• Ensure compliance with 21 CFR Part 11, GxP, data integrity, and electronic records/e-signatures.
• Collaborate with IT, Engineering, Quality, Manufacturing, Automation, and system owners.
• Support change controls, deviations, CAPAs, and system retirement activities.
• Assist with audit and inspection readiness activities for computerized systems.
• Maintain accurate validation documentation per procedures.

Skills

CSV experience

GxP knowledge

Documentation

Communication skills

Education

B.S. in Eng/CS/IT/LifeSci

Tools

Power BI

Job description

Validation & Engineering Group, Inc. is seeking a Computer System Validation (CSV) Specialist/Engineer to support validation activities for computerized systems in a regulated manufacturing environment.

The ideal candidate has 3–4 years of hands-on CSV experience and solid understanding of GxP, lifecycle documentation, and data integrity. Responsibilities include developing validation documentation, performing testing, and ensuring compliance with 21 CFR Part 11.