Validation Engineer

Job Title: Validation Engineer – CSV (MES/ERP Focus)

Company: Sanofi – FLEXT Direct (Contingent Workforce Program)

Pay Range: $75.00 - $98.00 per hour

Location: Swiftwater, PA

Contract Duration: 12 Months

Sanofi’s contingent workforce program, FLEXT Direct, is seeking an experienced Validation Engineer to support computerized system validation activities within a GMP-regulated pharmaceutical/biopharmaceutical manufacturing environment. This role will focus heavily on validation of MES (Manufacturing Execution Systems), ERP systems, and computerized equipment, ensuring compliance with regulatory and quality standards.

• Lead and execute Computerized System Validation (CSV) lifecycle activities for MES, ERP, and related systems
• Develop and review validation documentation including URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports
• Support computerized equipment qualification efforts
• Ensure compliance with GMP, Quality System Regulations (QSR), and 21 CFR Part 11
• Lead and support CAPA (Corrective and Preventive Action) investigations and remediation activities
• Partner cross-functionally with Quality, Manufacturing, IT, and Engineering teams
• Manage multiple validation projects while meeting strict deadlines
  
  Maintain accurate and audit-ready documentation

• Bachelor’s degree in Engineering or related technical discipline required
• Master’s degree preferred
• 6–9 years of experience in pharmaceutical, biopharmaceutical, or regulated manufacturing environment
• Demonstrated experience validating MES and/or ERP systems
• Strong understanding of validation lifecycle principles and regulatory compliance requirements
• Experience leading or supporting CAPA activities
• Detail-oriented with strong organizational skills
• Ability to manage multiple projects concurrently
• Strong written and verbal communication skills