Computer System Validation (CSV) Specialist

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

Position Summary

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 34 years of hands-on CSV experience and a solid understanding of GxP requirements, system lifecycle documentation, and data integrity principles.

Key Responsibilities

• Support the validation and lifecycle management of GxP computerized systems.

• Develop, review, and execute validation documentation, including:

• User Requirements Specifications (URS)

• Functional/Design Specifications

• Risk Assessments

• Validation Plans

• IQ/OQ/PQ protocols

• Test Scripts

• Traceability Matrices

• Validation Summary Reports

• 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.

Qualifications

• Bachelors degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related technical discipline.
• 34 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.

Preferred Qualifications

• 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.

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.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.