Germantown Equipment Operations Specialist
5 days ago
We are seeking an experienced professional to join our team at Precigen's Germantown, MD location as a key member of our mission to serve patients with innovative Gene Therapies. This role will require a technically savvy individual who thrives in a dynamic environment and possesses exceptional problem-solving skills, meticulous attention to detail, and proactive improvement initiatives.
About the RoleThis position provides Facility, Equipment, and Validation Engineering support to Precigen's GMP Manufacturing, Quality Control (QC), and Research and Development (R&D) facilities. The ideal candidate will oversee site Facility, Utility, and Equipment Maintenance Programs, coordinating with Metrology, Facilities, Validation, and User group personnel, as well as external vendors, to ensure proper operation of facility systems, process equipment, and analytical equipment.
- Ensure seamless operation of facility systems, including HVAC, backup power, water purification, compressed gas distribution, glass/part washers, autoclaves, refrigerators/freezers, incubators, tangential flow filtration (TFF), fast protein liquid chromatography (FPLC), centrifuges, polymerase chain reaction (PCR), environmental monitoring equipment, cell analysis, and spectrophotometers.
- Provide technical expertise to guide formation of calibration, qualification, and maintenance requirements for new site systems and update/improve 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 execute validation/engineering protocols/reports, such as temperature mapping of controlled temperature units (CTUs) and autoclaves using Kaye validator or similar data logging equipment.
- Support site Quality Management System (QMS) through authoring and reviewing 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.
- Bachelor's degree in Chemical, Biomedical, Mechanical, Electrical Engineering, or equivalent, and three years + of Good Manufacturing Practice (GMP) experience.
- Demonstrated experience using engineering principles to troubleshoot and repair mechanical/electrical equipment.
- Technical writing experience generating SOPs, protocols/reports, work instructions, and/or maintenance plans.
- Strong computer skills with Microsoft Office, CMMS, BMS/BAS, 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.
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