Facilities Manager

SUMMARY:

The Facilities Manager leads the site Facilities function and is accountable for ensuring the building, utilities and supporting infrastructure are maintained in a safe, compliant and inspection-ready state to support GMP manufacturing and general facility operations. This role manages facilities staff and third-party service providers, owns the building and utility maintenance program, and manages the facilities operating budget, service contracts and facility-related projects. The Facilities Manager partners closely with CMC, Quality, EHS and Engineering stakeholders to align facility priorities with business needs, drives continuous improvement in maintenance and reliability practices, and champions strict adherence to GMP and EHS requirements.

SUPERVISORY RESPONSIBILITIES:

* Directly supervise facilities technicians and building support staff, including hiring, training, work assignment, performance management and development.

* Manage the activities of third-party service providers and contractors working on site.

* Ensure adequate on-call support alarms and emergencies.

DUTIES AND RESPONSIBILITIES:

Maintenance and Reliability

* Own the building and utility maintenance program, including preventive and corrective maintenance, in accordance with GMP and GDP requirements to achieve a high level of equipment reliability and inspection readiness.

* Review equipment history and repair effectiveness to identify reliability concerns; evaluate and enhance PM strategies accordingly.

* Ensure timely investigation of equipment and utility deficiencies using root cause analysis, creative problem-solving and technical expertise to identify and resolve causal factors.

* Align maintenance activities with stakeholder schedules so maintenance and repairs are completed before due dates and without disrupting the manufacturing schedule.

* Ensure critical spare parts and stand-by equipment are identified and stocked to assure maximum capacity and reliability.

* Ensure daily, weekly and quarterly building, utility and manufacturing equipment inspections are performed and documented at the time of inspection, and that areas of concern are captured in work orders, scheduled and tracked to completion.

* Oversee BAS/BMS monitoring of HVAC performance and operating conditions, and ensure alarms are acknowledged and responded to appropriately.

* Own and manage the compressed gas program, including oversight of compressed gas change-outs on process equipment.

Vendor and Contract Management

* Select, manage and evaluate third-party service providers for manufacturing equipment, utilities (mechanical, HVAC, electrical, gases) and building maintenance activities.

* Ensure appropriate vendor service contracts are in place to support the maintenance program, including obtaining and processing vendor quotes, timely raising of new / modified service contracts and issuance of P.O.s.

* Ensure contractors are escorted and supervised, including in cleanroom areas, that documentation is completed at the time of service, and that work is performed in accordance with US WorldMeds EHS/GMP requirements.

Compliance, Quality and EHS

* Ensure all Facilities activities are performed in compliance with applicable cGMP regulations and FDA, USP and ISPE guidelines.

* Initiate, own and/or participate in GMP investigations, deviations, CAPAs and change controls related to building, utility and equipment maintenance and repairs.

* Develop, review and approve Facilities SOPs, and ensure maintenance records are organized, complete and in an inspection-ready state.

* Represent Facilities during regulatory inspections, client audits and internal audits.

* Partner with EHS to ensure facility compliance with OSHA, fire/life safety and environmental requirements, and support emergency preparedness and business continuity planning.

Projects and Continuous Improvement

* Lead Facilities and Engineering projects, including equipment installations and HVAC upgrades; review drawings, develop schedules, coordinate project activities with stakeholders and confirm work is performed as designed.

Building Support Services

* Oversee building support services, including conference room, meeting and event setup, kitchen and office inventory, and general building administration.

* Perform or support hands-on building and utility maintenance (e.g., minor carpentry, patching / painting, filter replacement) as needed. Some work may be required in a GMP clean room (gowning required).

* Other duties as assigned by management in support of a rapidly growing company.

QUALIFICATIONS:

* Bachelor's degree in Engineering, Facilities Management or a related technical field, or an equivalent combination of education and experience.

* 7+ years of facilities or maintenance experience with a wide range of building and utility systems within a GMP manufacturing environment, including 3+ years in a supervisory or management role.

* Prior experience in complex biotechnology and / or pharmaceuticals industry.

* Experienced with the GMP Quality Management system (deviations, CAPAs, change controls, etc.) and with completing GMP documentation related to maintenance activity.

* Demonstrated experience leading and developing staff, and managing budgets, service contracts and vendor performance.

* Working knowledge of HVAC, BAS/BMS, electrical, compressed gas and other critical utility systems.

* Proficiency with a CMMS and Microsoft Excel to plan, schedule and track maintenance so that all work is performed within due dates.

* Strong ability to analyze data, assess results and determine appropriate action, applying work methods with precision and accuracy to ensure quality results.

* Strong leadership, communication and organizational skills, with a resilient mentality to rapidly adjust to conflicting priorities and sudden scheduling changes.

* Capable of working independently with limited supervision as well as in a collaborative, cross-functional environment, and supportive of the business and its ideals and strategies.

PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT:

* Work is performed in a combination of office, mechanical/utility spaces, manufacturing areas and GMP clean rooms. Must be able to follow gowning procedures and work in gowned environments for extended periods.

* Must be able to stand, walk, climb stairs and ladders, bend, stoop, kneel and reach for extended periods while inspecting building systems and overseeing work.

* Must be able to lift, carry, push and pull up to 50 lbs. occasionally.

* May be exposed to mechanical and electrical equipment, noise, temperature extremes, compressed gases and chemicals. Must wear required personal protective equipment (PPE) and follow all EHS procedures.

* Must be able to work in confined or elevated spaces (e.g., mechanical rooms, mezzanines, rooftops) as required.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK SCHEDULE:

The individual may be required to support activities occurring overnight, on weekends and on holidays, including planned shutdowns, maintenance and project work, vendor services, and response to building and utility alarms or emergencies.