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    "requisitionDescription": "<div><p style=\"margin-left:0in;\">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&rsquo;s GMP Manufacturing, Quality Control (QC), and Research and Development (R&amp;D) facilities.</p><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\">Duties and Responsibilities:</p><ul style=\"list-style-type: disc;margin-left: 0in;\"><li>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</li><li>Controlled Temperature Mappings for CTU Qualifications&nbsp;</li><li>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</li><li>Participate on project teams requiring validation support to represent the function internally on specific projects</li><li>Author and Review Qualification Related Standard Operating Procedures (SOPs), Work Instructions (WI), and Validation Plans</li><li>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</li><li>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</li><li>Support site Quality Management System (QMS) through Authoring and Reviewing of Qualification related Change Controls, Deviations, and Corrective and Preventive Actions (CAPA)</li></ul><p style=\"margin-left:0in;\"><br></p><p style=\"margin-left:0in;\">EDUCATION AND EXPERIENCE:</p><ul style=\"list-style-type: disc;margin-left: 0in;\"><li>Bachelor&rsquo;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</li><li>Technical Writing experience generating Standard Operating Procedures (SOP), Protocols/Reports, Work Instructions, and Validation Plans</li><li>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</li><li>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</li></ul><p style=\"margin-left:0in;\"><br>&nbsp;EOE MFDV</p></div>\n",
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