CSV Engineer

Job Summary:

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

Education & Experience:

• 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