Associate​/Validation Engineer

Overview

We are seeking an Associate / Validation Engineer at our Germantown, MD location to join us in our mission to serve patients with our next generation of innovative Gene Therapies. This position requires a technically savvy professional who thrives in a dynamic team, possesses exceptional problem-solving skills, meticulous attention to detail, and is proactive in implementing improvements. This role provides Validation Engineering support to Precigen’s GMP Manufacturing, Quality Control (QC), and Research and Development (R&D) facilities.

• Oversee site Validation Program, coordinating with Metrology, Facilities, User group personnel, and external vendors to ensure proper qualification status of Facility systems (HVAC, Backup Power, Water Purification, Compressed Gas Distribution, Glass/Part Washers, Autoclaves, Refrigerator/Freezers), Process Equipment (Incubators, Tangential Flow Filtration (TFF), Fast Protein Liquid Chromatography (FPLC), Centrifuges), and Analytical Equipment (PCR, Environmental Monitoring Equipment, Cell Analysis, Spectrophotometers); perform hands-on troubleshooting and partner with OEMs or service vendors as needed.
• Controlled Temperature Mappings for CTU Qualifications.
• Provide technical expertise to guide qualification requirements for new site systems and update existing equipment/utilities per the site Validation Master Plan and Procedures.
• Participate on project teams requiring validation support to represent the function on specific projects.
• Author and review Qualification-Related SOPs, Work Instructions (WI), and Validation Plans.
• Author, review, and execution of Validation Protocols and Reports (e.g., temperature mapping of CTUs and Autoclaves using KAYE validator or similar data logging equipment), engineering studies, and IQ/OQ/PQ of facility, processing, and analytical equipment.
• Collect, compile, and analyze validation data with minimal supervision, demonstrating ownership of data to confirm the validated state of equipment for GMP use.
• Support site Quality Management System (QMS) through authoring and reviewing of Qualification-related Change Controls, Deviations, and CAPAs.

• Bachelor’s degree in Engineering or Life Sciences and 2+ years of GMP Qualification experience (level determined by education and experience) with working knowledge of FDA and Eudralex regulations.
• Technical Writing experience generating SOPs, Protocols/Reports, WI, and Validation Plans.
• Strong computer skills—familiarity with Microsoft Office, Quality Record Management, CMMS, Building Management/Automation Systems (BMS/BAS), Environmental Monitoring System (EMS), Validation Data Management Software, 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.

EOE MFDV