We are seeking a Lead Validation Engineer at our Germantown, MD location to join us in our mission to serve patients through innovative Gene Therapies. This position serves as a technical leader within the Validation function and provides validation engineering support for Precigen's GMP Manufacturing, Quality Control (QC), Facilities, and Research & Development (R&D) operations.
The ideal candidate will possess advanced expertise in equipment, utility, facility, and process qualification within regulated GMP environments. This individual will lead complex validation projects, develop validation strategies, provide technical guidance to cross-functional teams, and ensure compliance with applicable regulatory requirements. The successful candidate will be highly organized, technically proficient, detail-oriented, and capable of independently managing multiple high-priority initiatives while driving continuous improvement across the site validation program.
Duties and 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 Environmental Monitoring Performance Qualification (EMPQ), cleanroom qualification activities, airflow visualization (smoke studies), HVAC performance testing, and autoclave qualification/requalification programs.
- Execute and review controlled temperature unit (CTU) and autoclave temperature mapping studies utilizing Kaye Validators or equivalent data acquisition systems.
- Develop and facilitate risk assessments including impact assessments, failure mode and effects analyses (FMEA), and other risk-based validation methodologies.
- Collect, evaluate, trend, and interpret validation data to ensure systems remain in a qualified state and are suitable for GMP use.
- Provide technical oversight and review of qualification packages generated by internal personnel, contractors, consultants, and equipment vendors.
- Support the site Quality Management System (QMS) through authoring, investigation, and review of qualification-related deviations, change controls, corrective and preventive actions (CAPA), and periodic reviews.
- Support regulatory inspections, client audits, and internal audits as the Validation SME.
- Provide hands-on troubleshooting support and collaborate with original equipment manufacturers (OEMs) and service providers to resolve complex technical issues.
- Identify and implement continuous improvement opportunities that enhance compliance, efficiency, and effectiveness of validation programs.
Education and Experience
- 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
- Environmental Monitoring Performance Qualification (EMPQ)
- Airflow Visualization (Smoke Studies)
- Controlled Temperature Unit (CTU) Qualification and Temperature Mapping
- Utility Qualification (Compressed Gas, Water, and Clean Utility Systems)
- Equipment IQ/OQ/PQ Activities
- Experience authoring and reviewing Validation Master Plans, Validation Protocols, Validation Reports, Risk Assessments, SOPs, and Work Instructions.
- Experience supporting investigations, change controls, deviations, CAPAs, and periodic reviews within a GMP Quality Management System.
- Strong understanding of FDA regulations, EU GMP requirements, Annex 1, Data Integrity principles, and industry best practices for qualification and validation.
- Excellent technical writing, problem-solving, organizational, and project management skills.
- Strong computer skills- familiarity with Microsoft Office, Quality Record Management, Computerized Maintenance Management Systems(CMMS), Building Management/Automation Systems (BMS/BAS), Environmental Monitoring System(EMS), Validation Data Management Software, Computer Aided Design (CAD) and the ability to quickly learn new applications
- Ability to sit, stand, and walk regularly to access mechanical areas and aseptically gown into production suite. Able to maneuver equipment and supplies up to 40 pounds
- Occasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.
