Senior Validation Engineer

Join my client’s cutting-edge radiopharmaceutical manufacturing operation and play a pivotal role in bringing life-changing therapies to patients. As the Senior Validation Engineer, you’ll lead site startup, facility qualification, and GMP equipment validation in a highly specialized, radiation-controlled environment. This is your opportunity to shape compliant, inspection-ready systems from the ground up in a rapidly advancing sector of biotech.

• High-impact role supporting innovative radiopharmaceutical production
• Lead site startup and expansion initiatives in a regulated GMP setting
• Work with advanced systems: hot cells, isolators, synthesis modules
• Competitive salary range: $120,000 – $185,000 Depending on level and experience
• Comprehensive benefits package including medical, 401(k), and PTO

• Lead facility, utility, and cleanroom (ISO) qualification activities
• Develop and execute Validation Master Plans (VMP)
• Author and execute URS, DQ, IQ, OQ, PQ protocols
• Oversee qualification of HVAC, WFI, clean steam, gases, and water systems
• Support FAT/SAT, manage deviations, CAPAs, and change controls
• Serve as SME during FDA and regulatory inspections

• Bachelor’s degree in Engineering or related technical field
• Strong expertise in GMP commissioning & qualification lifecycle (ASTM E2500 preferred)
• Hands-on experience in aseptic manufacturing environments
• Experience with radiopharma systems (hot cells, shielded isolators, synthesis modules)
• Deep knowledge of 21 CFR 210/211 and radiation safety regulations

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to  and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19738.