Validation Engineer

Responsibilities

• Develop, review, and execute validation documentation, including protocols, reports, and risk assessments
• Conduct commissioning and qualification activities for utilities, manufacturing equipment, and support systems
• Verify design and installation against specifications, drawings, and regulatory requirements
• Perform field inspections, functional testing, and data analysis to ensure compliance and performance
• Collaborate with engineering, operations, quality, and automation teams to coordinate validation activities
• Participate in factory and site acceptance testing (FAT/SAT) and ensure proper documentation is completed
• Troubleshoot technical issues identified during validation and recommend corrective actions
• Maintain accurate, organized, and audit-ready records for all validation activities
• Ensure compliance with cGMP, FDA, ICH, and other applicable regulatory standards throughout the validation process
• Support continuous improvement initiatives to enhance validation processes and efficiency

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field
• 3+ years of experience in a regulated manufacturing environment (pharmaceutical, biotech, or medical device preferred)
• Strong understanding of the CQV lifecycle, including FAT, SAT, IQ, OQ, and PQ activities
• Experience with risk-based validation approaches and industry standards such as GAMP 5
• Ability to read and interpret engineering drawings, P&IDs, and technical specifications
• Strong problem-solving, analytical, and documentation skills
• Effective communication and teamwork abilities in cross-functional environments