Sr. Validation Engineer

Job Responsibilities:

• Lead equipment, facility, utility, and process validation activities (IQ/OQ/PQ)
• Author, review, and execute validation protocols and summary reports
• Ensure compliance with FDA, EMA, and cGMP regulations
• Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams
• Drive continuous improvement in validation strategies and risk-based approaches

Job Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 4+ years of validation experience in a CDMO, pharma, or biotech environment
• Strong knowledge of GMP validation requirements and risk-based validation (e.g., ASTM E2500)
• Experience with cleanroom validation, autoclaves, SIP/CIP, and process equipment
• Excellent technical writing and communication skills