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 CSV Engineer 4.0 4.0 out of 5 stars Bloomfield, IN 47424 Contract Katalyst Healthcares & Life Sciences 4 reviews

Contract 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