Quality Assurance – Computer System Validation (CSV)

Role Summary

As the Quality Assurance – Computer System Validation (CSV), you will be part of the Quality organization supporting Clinton Manufacturing Operations. In this role, you will provide quality oversight for computerized systems used in GxP operations, ensuring compliance with global regulatory requirements and data integrity standards. You will partner with IT, Automation, Engineering, and Production teams to maintain validated systems and integrate compliant digital solutions across the site.

Responsibilities

• Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
• Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
• Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis
• Partner cross-functionally with IT, Engineering, Automation, and Operations to implement and maintain compliant computerized systems
• Support continuous improvement of site Quality Systems through SOP development, training, coaching, and change control management

Qualifications

• Required: Education: Bachelor’s Degree in Science, Technology, Engineering, Computer Science, or a related technical discipline (or equivalent experience)
• Required: Experience: Minimum 5–7 years of experience in a GxP regulated environment (Pharmaceutical, Biotech, or Medical Device), including at least 3–5 years of experience in Computer System Validation (CSV) or Computer System Quality Assurance (CSQA)
• Required: Top 2 Skills: Strong knowledge of Data Integrity and computerized system validation regulations (21 CFR Part 11, Annex 11, ALCOA++), and ability to influence and coach cross-functional technical teams on compliance requirements
• Preferred: Professional certifications such as CISA (Certified Information Systems Auditor) or CSQE (Certified Software Quality Engineer)
• Preferred: Experience supporting Data Integrity audits and regulatory inspections
• Preferred: Experience with regulated system platforms such as SAP, Veeva, MES, or LIMS
• Preferred: Experience implementing risk-based validation approaches aligned with GAMP 5
• Preferred: Experience supporting manufacturing or laboratory systems in regulated environments

Additional Requirements

• Location: Clinton, IN – Onsite Manufacturing Facility