Computer System Validation (CSV) Specialist

About the role

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.
• 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

• 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.

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.