What are the responsibilities and job description for the Validation Engineer position at Precigen, Inc?
Job Description
Job Description
Validation Engineer
We are seeking a 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
- 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 :
EOE MFDV
