Computer System Validation (CSV) Specialist at Pinnaql in Wilson, NC
- Company: Pinnaql
- Location: Wilson, NC
- Posted: Sep 17, 2026
- Type: Full-time
- Experience: 4+ years
Overview
We are seeking a Computer System Validation (CSV) Specialist/Engineer to support validation activities for computerized systems in a regulated manufacturing environment. The ideal candidate will have 3–4 years of hands-on CSV experience and a solid understanding of GxP requirements, system lifecycle…
Job description
- We are seeking a Computer System Validation (CSV) Specialist/Engineer to support validation activities for computerized systems in a regulated manufacturing environment. The ideal candidate will have 3–4 years of hands-on CSV experience and a solid understanding of GxP requirements, system lifecycle documentation, and data integrity principles.
Responsibilities
- Support the validation and lifecycle management of GxP computerized systems.
- Functional/Design Specifications
- Risk Assessments
- Validation Plans
- IQ/OQ/PQ protocols
- Test Scripts
- Traceability Matrices
- Execute and document system testing and ensure appropriate resolution of discrepancies and deviations.
- Support system implementation, upgrades, enhancements, and periodic reviews.
- Perform computerized system risk assessments in accordance with applicable regulatory requirements and company procedures.
- Ensure compliance with 21 CFR Part 11, GxP, data integrity, and electronic records/electronic signature requirements.
- Collaborate with IT, Engineering, Quality, Manufacturing, Automation, and system owners throughout the system lifecycle.
- Support change controls, deviations, CAPAs, and system retirement activities as applicable.
- Assist with audit and inspection readiness activities related to computerized systems.
- Maintain accurate and complete validation documentation in accordance with approved procedures.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related technical discipline.
- 3–4 years of experience in Computer System Validation (CSV) within a regulated environment, preferably pharmaceutical, biotechnology, medical device, or life sciences manufacturing.
- Working knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles.
- Experience developing and executing computerized system 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.
- Experience with Power BI for dashboards, reporting, data visualization, or analytics.
- Experience validating manufacturing, laboratory, quality, or enterprise systems.
- Experience supporting system upgrades, implementation projects, or digital transformation initiatives.
Skills
Required
- Working knowledge of GAMP 5
- 21 CFR Part 11
- GxP
- Data integrity principles
- Strong documentation skills
- Analytical skills
- Problem-solving skills
About Pinnaql
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Computer System Validation Specialist At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Excited to build something meaningful together? We look forward to hearing from you.