We are seeking a 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 will require a professional who is technically savvy, thrives in a dynamic team environment, poses exceptional problem-solving skills, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will provide Validation Engineering support to Precigen's GMP Manufacturing, Quality Control (QC), and Research and Development (R&D) facilities.
Duties and Responsibilities:
- Oversee site Validation Program, coordinating with Metrology, Facilities, and User group personnel, as well as external vendors, to ensure the proper qualification status of Facility systems [e.g. Heating Ventilation and Air Conditioning (HVAC), Backup Power, Water Purification, Compressed Gass Distribution, Glass/Part Washers, Autoclaves, Refrigerator/Freezers], Process Equipment [e.g. Incubators, Tangential Flow Filtration (TFF), Fast Protein Liquid Chromatography (FPLC), and Centrifuges], and Analytical Equipment [e.g. Polymerase Chain Reaction (PCR), Environmental Monitoring Equipment, Cell Analysis, Spectrophotometers]. Hand-on troubleshooting, partnership with Original Equipment Manufacturer (OEM) or service vendors, as needed
- Controlled Temperature Mappings for CTU Qualifications
- Provide technical expertise to guide formation of qualification requirements for new site systems and update/improvement of existing equipment/utilities per site Validation Master Plan and Procedures
- Participate on project teams requiring validation support to represent the function internally on specific projects
- Author and Review Qualification Related Standard Operating Procedures (SOPs), Work Instructions (WI), and Validation Plans
- Author, Review, and Execution of Validation Protocols and Reports, such as temperature mapping of Controlled Temperature Units (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 and information with some or minimal supervision, demonstrating ownership of data to confirm the validated state of the equipment for GMP use
- Support site Quality Management System (QMS) through Authoring and Reviewing of Qualification related Change Controls, Deviations, and Corrective and Preventive Actions (CAPA)
EDUCATION AND EXPERIENCE:
- Bachelor's degree in Engineering or Life Sciences and Two (2) + years of Good Manufacturing Practice (GMP) Qualification experience (Level will be determined based on education and experience) with working knowledge of FDA and Eudralex regulations
- Technical Writing experience generating Standard Operating Procedures (SOP), Protocols/Reports, Work Instructions, and Validation Plans
- 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
