Validation Engineer
Rohan S.United StatesMIDPosted 5d ago
cGMPvalidation protocolstechnical documentationrisk assessmentregulatory complianceSOPsquality systemschange controlCAPAIQOQPQ
About the Role
We are looking for a Validation Engineer to support qualification and validation activities in a pharmaceutical manufacturing environment. This role requires expertise in cGMP, validation protocols, technical documentation, risk assessment, and regulatory compliance.
Key Responsibilities
• Perform equipment, process, facility, utility, and cleaning validation
• Develop validation protocols, test plans, and acceptance criteria
• Ensure compliance with cGMP, pharmaceutical manufacturing standards, and regulatory requirements
• Conduct validation studies, data analysis, and technical documentation
• Maintain SOPs, quality systems, risk assessment, and change control processes
• Coordinate cross-functionally with Engineering, Manufacturing, QA, QC, and Regulatory Affairs teams
• Provide support for internal and external inspections
Requirements
• Bachelor’s degree in Engineering or a related science field
• 3+ years of relevant experience in pharmaceutical validation
• Master’s degree with 2+ years of experience may be considered