Senior Validation Engineer – GMP Systems & Compliance Lead

Precigen, Inc; Germantown (MD); On-site; USD 130,000 - 140,000; Full time

Job summary

Precigen, Inc in Germantown, MD is seeking a Lead Validation Engineer to act as technical leader in the Validation function. You will provide validation support for GMP Manufacturing, QC, Facilities, and R&D, guiding cross-functional teams and developing risk-based qualification strategies.

The role requires advanced expertise in equipment, utility, facility, and process qualification in GMP environments, leading complex projects, and ensuring regulatory compliance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related scientific discipline required.
• Minimum of five (5) years of GMP validation and qualification experience within the pharmaceutical, biotechnology, medical device, cell therapy, gene therapy, or related regulated industry.
• Demonstrated experience independently leading complex validation projects and coordinating cross-functional teams.
• Extensive experience with equipment, utility, facility, and process qualification programs within GMP environments.
• Proven experience performing and leading: Autoclave Qualification and Requalification, EMPQ, Airflow Visualization, CTU Qualification, Utility Qualification, Equipment IQ/OQ/PQ.
• Experience authoring and reviewing Validation Master Plans, Validation Protocols, Validation Reports, Risk Assessments, SOPs, and Work Instructions.

Responsibilities

• Provide technical leadership for site validation and qualification activities supporting GMP manufacturing, laboratory, utility, and facility systems.
• Lead complex qualification and validation projects from concept through implementation, including new equipment installations, facility expansions, process improvements, utility modifications, and major change control initiatives.
• Serve as a Validation Subject Matter Expert (SME) for GMP facilities, utilities, process equipment, analytical instruments, and qualification lifecycle management.
• Coordinate with Facilities, Metrology, Manufacturing, Quality, R&D personnel, contractors, and equipment vendors to maintain validated systems and ensure compliance with regulatory requirements.
• Oversee qualification activities for facility systems including HVAC, backup power systems, water purification systems, compressed gas distribution systems, clean utility systems, autoclaves, glass washers, part washers, controlled temperature units, refrigerators, and freezers.
• Provide qualification support for process and analytical equipment including incubators, biosafety cabinets, centrifuges, chromatography systems, filtration systems, PCR systems, environmental monitoring equipment, and laboratory instrumentation.
• Develop validation strategies and qualification approaches using risk-based methodologies consistent with FDA, EU GMP, ISPE, ASTM, and GAMP principles.
• Author, review, approve, and execute Validation Master Plans, Validation Plans, Risk Assessments, Commissioning and Qualification Plans, Protocols, Reports, SOPs, and Work Instructions.
• Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for facilities, utilities, equipment, and systems.
• Perform and lead EMPQ, cleanroom qualification activities, airflow visualization (smoke studies), HVAC testing, and autoclave qualification/requalification programs.
• Execute and review CTU and autoclave temperature mapping studies utilizing data acquisition systems.
• Develop and facilitate risk assessments including FMEA and other risk-based validation methodologies.
• Collect, evaluate, trend, and interpret validation data to ensure systems remain qualified for GMP use.
• Provide technical oversight and review of qualification packages.
• Support the site QMS through authoring, investigation, and review of deviations, CAPA, and periodic reviews.
• Support regulatory inspections, client audits, and internal audits as the Validation SME.
• Provide hands-on troubleshooting and collaborate with OEMs to resolve issues.
• Identify and implement continuous improvement opportunities for validation programs.

Skills

GMP validation

Leadership

Regulatory compliance

Technical writing

Project management

Cross-functional teams

Education

Bachelor's degree in Engineering

Tools

CMMS

CAD

EMS

BMS

Job description

Precigen, Inc in Germantown, MD is seeking a Lead Validation Engineer to act as technical leader in the Validation function. You will provide validation support for GMP Manufacturing, QC, Facilities, and R&D, guiding cross-functional teams and developing risk-based qualification strategies.

The role requires advanced expertise in equipment, utility, facility, and process qualification in GMP environments, leading complex projects, and ensuring regulatory compliance.