Equipment Engineer

1 week ago

Germantown, United States Precigen Full time

We are seeking an experienced Equipment Engineer / Senior Equipment 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 Facility, Equipment, and Validation Engineering support to Precigen's GMP Manufacturing, Quality Control (QC), and Research and Development (R&D) facilities.

Duties and Responsibilities:

  • Oversee site Facility, Utility, and Equipment Maintenance Programs, coordinating with Metrology, Facilities, Validation, and User group personnel, as well as external vendors, to ensure the proper operation of Facility systems [e.g. Heating Ventilation and Air Conditioning (HVAC), Backup Power, Water Purification, Compressed Gas 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 calibration, qualification, and maintenance requirements for new site systems and update/improvement of existing equipment/utilities
  • Manage site Facility and Equipment drawings in Computer Aided Design (CAD) software
  • Author and Review Facility and Equipment Related Standard Operating Procedures (SOPs), Work Instructions (WI)
  • Author, Review, and Execution of Validation/Engineering Protocols/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
  • Support site Quality Management System (QMS) through Authoring and Reviewing of Equipment/Facility related Change Controls, Deviations, and Corrective and Preventive Actions (CAPA)
  • Lead site Capital Expenditure (CAPEX) projects, coordinating with vendors, consultants, contractors to implement site upgrades
  • Partner with Safety Staff to ensure facility is maintained in a safe and compliant state
EDUCATION AND EXPERIENCE:
  • Bachelor's degree in Chemical, Biomedical, Mechanical, Electrical Engineering or equivalent and Three (3) + years of Good Manufacturing Practice (GMP) experience (Level will be determined based on education and experience)
  • Demonstrated experience using engineering principles to troubleshoot and repair mechanical/electrical equipment.
  • Technical Writing Experience generating Standard Operating Procedures (SOP), Protocols/Reports, Work Instructions, and/or Maintenance Plans
  • Strong computer skills with Microsoft Office, 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.

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