Scientific Search · 21 hours ago
Senior Validation Engineer
Andover, MA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $185K/yrScientific Search is seeking a Senior Validation Engineer to join their cutting-edge radiopharmaceutical manufacturing operation. In this role, you will lead site startup, facility qualification, and GMP equipment validation, ensuring compliance in a highly specialized environment.
Human ResourcesStaffing Agency
No H1B
U.S. Citizen Only
Responsibilities
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
Qualification
Required
Must have Green Card or Citizenship
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
Benefits
Comprehensive benefits package including medical, 401(k), and PTO
Company
Scientific Search
Scientific Search is a staffing and recruiting company offering pharmaceutical, engineering, and it recruiting services.
Founded in 1983
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase