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# CSV Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Bloomfield, IN, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Audit Trail, Data Integrity, Requirements Traceability, System Testing, Iq/oq/pq, Information Technology, GXP
- **Published:** September 18, 2026
- **Apply:** https://www.careerjet.com/job/us174ec1ced0d231c5ebdbf254d5898a40/eaa

## About the Role

* Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field
 * Minimum of 7+ years of experience in Computer System Validation within a pharmaceutical or GMP-regulated environment
 * Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches
 * Hands-on experience with automation and control systems (e.g., DeltaV, PI Historian, Rockwell PLC, HMI)
 * Proven experience supporting 21 CFR Part 11 compliance and data integrity requirements
 * Excellent documentation, communication, and stakeholder management skills

## Description

The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana.
Roles & Responsibilities:

 * Execute and manage computer system validation (CSV) activities in compliance with GAMP 5 and GMP regulations
 * Develop and review validation documentation including Validation Plans, URS (User Requirement Specifications), FS (Functional Specifications), DS (Design Specifications), and protocols (IQ/OQ/PQ)
 * Perform and oversee execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
 * Ensure compliance with 21 CFR Part 11 requirements, including electronic records, audit trails, and data integrity
 * Work with automation and control systems such as DeltaV, PI Historian, Rockwell PLC, HMI, or similar platforms
 * Apply risk-based validation approaches and V-model lifecycle principles
 * Maintain and manage validation documentation such as RTMs (Requirement Traceability Matrices), validation summary reports, and SOPs
 * Collaborate with cross-functional teams including Automation, Quality Assurance, and IT
 * Support internal and external audits by providing validation documentation and compliance evidence


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