CSV Engineer

We are seeking an experienced CSV Engineer to ensure that computerized systems meet regulatory standards and industry best practices. This role involves validating and maintaining software applications, lab instruments, and manufacturing automation systems (e.g., DeltaV, MES).

The CSV Engineer will collaborate closely with cross-functional teams, conducting risk assessments, executing validation protocols, and preparing comprehensive validation documentation to support regulatory inspections and audits.

Key Requirements:

• Bachelor's in Computer Science, Engineering, or related field
• In-depth knowledge of regulatory guidelines (FDA 21 CFR Part 11, EU Annex 11, GAMP 5)
• Strong experience with validation protocols, risk-based approaches, and documentation management
• Familiarity with SDLC, change control, and data integrity principles

Experience Required:

5+ Years in regulated industry (preferably Pharma or Biotech)

Join us and leverage your CSV expertise to impact the pharmaceutical and biotech industries.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.