Validation Engineer

Responsibilities

• Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, and cleaning processes
• Support tech transfer projects by authoring and reviewing risk assessments, validation plans, and test methods
• Write and revise qualification documents including SOPs, master validation plans, URS, and FRS
• Prepare summary reports for validation, commissioning, and requalification activities
• Perform P&ID walkdowns to verify installation and system readiness
• Conduct thermal mapping of temperature-controlled chambers and warehouses
• Support resolution of regulatory observations and audit findings

Requirements

• Bachelor’s degree in life science, engineering, or a related technical field
• 4–7 years of experience in biotech, pharmaceutical, or medical device industries
• Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles
• Hands-on experience with equipment, computerized systems (CSV), and process validation
• Proven experience writing IQ, OQ, PQ, and CSV reports

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.