Lead Validation Engineer
Overview:
In this role you lead the validation program for GMP manufacturing, QC, facilities, and R&D at Precigen's Germantown site. You will craft validation strategies, mentor cross-functional teams, and ensure regulatory compliance across equipment, utilities, and processes. You'll manage complex qualification projects from concept to implementation and drive continuous improvement of the site validation program. This position combines technical leadership with hands-on problem solving in a fast-paced, regulated environment. Your work helps enable high-quality gene therapy manufacturing and patient safety.
Responsibilities:
Provide technical leadership for site validation and qualification across manufacturing, laboratory, utility, and facility systems.
Lead complex qualification/validation projects from concept to implementation, including new equipment, facility expansions, process improvements, and major change controls.
Serve as Validation SME for GMP facilities, utilities, equipment, analytical instruments, and qualification lifecycle management.
Coordinate with Facilities, Metrology, Manufacturing, Quality, R&D, contractors, and vendors to maintain validated systems and regulatory compliance.
Oversee qualification activities for HVAC, backup power, water systems, clean utilities, autoclaves, washers, and controlled temperature units.
Provide qualification support for incubators, biosafety cabinets, centrifuges, chromatography, filtration, PCR, environmental monitoring, and laboratory instrumentation.
Develop validation strategies using risk-based methodologies aligned with FDA, EU GMP, ISPE, ASTM, and GAMP principles.
Author/review/approve Validation Master Plans, Plans, Risk Assessments, Protocols, Reports, SOPs, and Work Instructions.
Key requirements:
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related discipline
- Minimum five years of GMP validation and qualification experience in pharmaceutical/biotech/gene therapy or related regulated industry
- Proven experience leading complex validation projects and coordinating cross-functional teams
- Extensive experience with equipment, utility, facility, and process qualification in GMP environments
- Experience authoring/reviewing Validation Master Plans, Protocols, Reports, Risk Assessments, SOPs, and WIsStrong knowledge of FDA/EU GMP/Annex 1 and data integrity principles
- Excellent technical writing, problem-solving, organizational, and project management skills
- Proficiency with MS Office, QMS, CMMS, BMS/BAS, EMS, validation data management software, CAD; ability to learn new tools quickly
- Physical ability to access mechanical areas and gown into production suites; able to move up to 40 poundsstrong communicationcross-functional collaborationattention to detailIQ/OQ/PQ executionEMPQ and cleanroom qualificationairflow visualization (smoke studies)