Validation Engineer – Sterile Manufacturing

Job Summary

We are seeking Validation Engineers to support equipment and process validation activities for products being transferred to a new GMP manufacturing site. This role will focus on revalidation, PPQ support, and ongoing validation programs within a sterile manufacturing environment.

Key Responsibilities

• Execute and support equipment and process revalidation activities
• Support PPQ and tech transfer validation efforts
• Perform media fills and process simulations
• Support CPV and requalification programs
• Author/review validation protocols and reports (IQ/OQ/PQ/PPQ)
• Prepare media fill reports and support quality reviews
• Ensure compliance with cGMP and regulatory requirements
• Collaborate with QA, Manufacturing, and Engineering teams

Required Qualifications

• 4–7 years of validation experience in pharma/biotech
• Strong sterile manufacturing validation experience
• Hands-on experience with media fills, process simulations, and AVI
• Experience with IQ/OQ/PQ/PPQ
• Strong GMP knowledge