CSV Engineer

KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.

We are seeking an experienced Computer System Validation (CSV) Engineer to support facility-based projects, OEM equipment qualification, and Delta

V system integration. The ideal candidate will bring strong expertise in CSV activities across the system lifecycle, from URS development through installation and operational verification. This role requires a detail-oriented professional with the ability to review specifications, ensure compliance with regulatory standards, and perform thorough look-checks during equipment installation. No coding experience is required.

• Develop, review, and approve User Requirement Specifications (URS), functional specifications, and design documentation.
• Perform and document CSV activities in accordance with GAMP 5, FDA, EMA, and 21 CFR Part 11 guidelines.
• Conduct look-checks and verification during equipment installation and startup to ensure alignment with specifications.
• Support OEM equipment qualification and vendor documentation reviews for compliance and completeness.
• Interface with facilities, OEMs, and automation teams to ensure seamless integration and validation of systems (including Delta
  
  V).
• Prepare, execute, and review validation deliverables such as IQ/OQ protocols, test scripts, and summary reports.
• Provide change control and deviation management support as related to CSV deliverables.
• Ensure inspection readiness by maintaining accurate documentation and adhering to company SOPs and regulatory expectations.

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field (or equivalent experience).
• Minimum 5 years of hands-on experience in CSV within a pharmaceutical, biotech, or regulated manufacturing environment.
• Strong knowledge of CSV regulations and industry guidance (GAMP 5, FDA, EMA, 21 CFR Part 11, Annex 11).
• Experience with Delta
  
  V system validation (no coding required).
• Familiarity with facility and OEM equipment validation/qualification.
• Proven ability to review technical specs and perform compliance checks during installation.
• Excellent documentation, organizational, and communication skills.