CSV Engineer

Katalyst HealthCares & Life Sciences

CSV Engineer

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 And 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 And 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

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Vacancy posted 2 days ago

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