Facilities Specialist

Key ResponsibilitiesFollow all applicable quality systems, policies, and procedures to ensure products meet safety, quality, and regulatory standardsPerform maintenance, troubleshooting, and repair on production equipment, laboratory systems, and facility infrastructureDiagnose and resolve issues related to mechanical, electrical, pneumatic, and control systems, including motors, pumps, HVAC, vacuum systems, and process utilitiesSupport maintenance and repair of specialized manufacturing equipment such as isolator systems, filling/packaging lines, and associated utilitiesRead and interpret technical documentation including P&IDs, wiring diagrams, system layouts, and equipment specificationsSupport continuous operations in a 24/7 manufacturing environment following site startupDevelop, revise, and maintain SOPs, work instructions, and maintenance documentationPerform calibration and ensure functionality of monitoring and detection equipment as requiredAccurately document maintenance activities, work orders, and asset history within a CMMSAssist in spare parts identification and inventory supportProvide responsive technical support to internal stakeholders with a focus on minimizing downtimeParticipate in equipment startup, commissioning, and qualification activitiesSupport investigations, deviations, and CAPAs from a maintenance/engineering perspectiveExecute preventative and corrective maintenance within controlled or cleanroom environmentsEnsure all documentation is completed in compliance with cGMP standardsTrain and mentor junior technicians as neededPerform additional duties as assignedQualifications & RequirementsHigh school diploma or equivalent required; associate or bachelor’s degree preferredMinimum 3+ years of hands-on maintenance experience in a regulated manufacturing environment (GMP strongly preferred)Experience supporting aseptic processing, fill/finish operations, or highly controlled production environments is a plusBackground in pharmaceutical, biotech, or medical device industries preferredFamiliarity working in environments involving hazardous or controlled materials is a plusStrong understanding of regulatory and safety standards (e.g., OSHA, FDA, etc.)Effective communication, teamwork, and organizational skillsProficiency with Microsoft Office, CMMS platforms, and building management systemsAbility to lift up to 50 lbs and perform physical tasks such as climbing laddersWillingness to work in controlled environments requiring PPE, including cleanrooms and confined spacesFlexibility to work off-shift hours, weekends, or holidays as required