Facilities Manager

Overview Facility Maintenance Manager will oversee day-to-day activities including management of the site maintenance program and facilities’ related projects. The manager will execute facility services projects, lead and influence cross functional teams, and implement corporate lean initiatives through reliability engineering and predictive maintenance activities. DUTIES & RESPONSIBILITIES Responsible for overseeing all day-to-day activities within the functional areas, including performance management. Responsible for making daily adjustments to the planned work schedule, including reassigning tasks as necessary due to emergency or high priority unplanned work. Responsible for cGMP training compliance, career development, performance reviews, skill training, and cross-training of direct reports. Supports manufacturing/process equipment and pharmaceutical support utilities, including but not limited to scales, tanks/agitators, parts washer, incubators, pumps, filling & lyo equipment, isolators, pure steam generation, packaging & labelling equipment, inspection booths, HVAC units, air compressors, automation/controls/PLCs, gas systems, electrical distribution equipment, chillers, waste neutralization system, hot water heating systems, refrigerators, cold room storage, cleanrooms, autoclaves, and water for injection (WFI) & purification systems. Evaluate system failures to determine root cause, troubleshoot and repair site-wide equipment Completion of all work orders and time entries in the CMMS system. Completion of all assigned training modules, SOPs, safety, and compliance requirements Preventative Maintenance/Predictive Maintenance – Daily/weekly/monthly/annual checks, PMs of site-wide equipment Manage, schedule, coordinate and oversee biannual facility maintenance shutdowns Support CAPEX projects for site-wide equipment Initiate, manage, and direct projects for facility improvements and other building/site renovations Program and maintain building control systems Align and manage customer expectations within all areas of operational activities and ensure that effective relationships are maintained with customers. Drive innovation through the development of best practices, operational efficiency that would support operational excellence goals. With the assistance of the safety manager, ensure that all employees adopt and use safe work practices in accordance with OSHA regulations. Responsible for the day-to-day coordination of calibration activities, testing and troubleshooting process control instrumentation in compliance ISO (9001 Quality Management Systems & 17025 Testing and calibration Laboratories) and with our standards operating procedures Coordinate and interact effectively with System Owners, vendors, and technical teams in the development of calibration procedures and with the definition of instrument and process tolerances Investigate equipment and instruments failures and lead the RCA in support of investigations Comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation Conduct and document regular inspections, maintenance and calibration of facilities and equipment Coordinate and document metrology activities for utilities, process equipment, and lab equipment. EDUCATION AND/OR TRAINING Knowledge of cGMP, 21CFR, Part 11, GAMP, GDP requirements and FDA regulations Aseptic gowning experience and training required Direct experience with regulated environments (i.e., cGMP, OSHA, EPA). General understanding of Quality Systems Working knowledge of pharmaceutical/biotech processes • Computer-savvy with SAP experience CMMS / Maximo experience strongly preferred Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio Able to read and understand construction drawings and blueprints WORK EXPERIENCE 8+ years of progressive experience in pharmaceutical, biotech, life sciences, medical device, or related industry 8+ years in cGMP facilities management 5+ years of experience overseeing capital projects & biannual facility maintenance shutdowns 5+ years managing facility and maintenance teams Greenfield/Brownfield site or facility expansion construction and startup experience Facility startup and CQV experience Experience interacting with FDA during inspection and audit PREFERRED QUALIFICATIONS Sterile fill finish manufacturing and/or Drug Product Ops experience Demonstrated a working knowledge of pharmaceutical manufacturing equipment as well as facility and utility equipment Thought leader in facilities design, build, maintenance, and management Strong track record of meeting objectives with a sense of urgency and driving operational excellence and continuous improvement HVAC, Air handling units, Refrigeration and cleanroom General repairs related to Painting, Carpentry, Plumbing / Pipefitting, Electrical, Mechanical, etc. Ability to read/interpret engineering drawings (Electrical, Mechanical, etc.), design documents, P&IDs, PFDs, and System boundary drawings #J-18808-Ljbffr