Facilities Lead

Job Requirements

Education and Experience

• B.S. degree in Engineering, Facilities Management, Maintenance, or a related technical field with 8+ years of relevant experience, including leadership responsibilities.


• High School diploma with 12+ years of progressive experience in pharmaceutical, biotechnology, manufacturing, facilities, utilities, or maintenance environments, including leadership experience.


• Demonstrated experience supporting facilities and manufacturing operations in a GMP-regulated environment.


• Experience managing contractors, vendors, maintenance activities, and facility projects.

Preferred Qualifications

• Experience with CMMS platforms such as Maximo, SAP PM, Oracle, Blue Mountain, or similar.


• Experience supporting Commissioning, Qualification, and Validation (CQV).


• Strong knowledge of GMP requirements and pharmaceutical manufacturing environments.


• Knowledge of FDA 21 CFR Parts 210, 211, and Part 11.


• Familiarity with ISPE Good Practice Guides.


• Experience with cleanroom facilities and controlled environments.


• Experience with HVAC systems, environmental controls, BMS, and critical facility utilities.


• Experience supporting facility expansions, capital projects, and new manufacturing spaces.


• Experience with Reliability-Centered Maintenance (RCM) and risk-based maintenance strategies.


• Knowledge of predictive maintenance technologies.


• Experience supporting regulatory inspections, customer audits, and internal audits.

Knowledge, Skills & Abilities

• Strong leadership and decision-making skills.


• Strong understanding of pharmaceutical facilities, utilities, cleanrooms, and maintenance principles.


• Knowledge of GMP requirements applicable to pharmaceutical manufacturing facilities.


• Understanding of HVAC systems and environmental control requirements for classified areas.


• Working knowledge of Building Management Systems (BMS) and facility monitoring systems.


• Strong understanding of facility and equipment lifecycle management.


• Excellent organizational and project management skills.


• Ability to prioritize multiple competing activities in a fast-paced manufacturing environment.


• Strong analytical, troubleshooting, and problem-solving skills.


• Excellent written and verbal communication skills.


• Strong contractor and vendor management capabilities.


• Proficiency with Microsoft Office and CMMS software.


• Ability to interpret engineering drawings, P&IDs, equipment manuals, specifications, and technical documentation.


• Strong cross-functional collaboration and stakeholder management skills.


• Ability to work effectively with Engineering, Manufacturing, Quality, Validation, and EHS.


• Commitment to safety, quality, GMP compliance, reliability, and continuous improvement.

Job Responsibilities

Facilities Leadership & Operations

• Provide day-to-day leadership and oversight of facility operations, maintenance, utilities, and infrastructure.


• Ensure facilities supporting manufacturing, laboratories, quality, and business operations remain safe, reliable, compliant, and operational.


• Establish facility maintenance priorities based on operational needs, equipment criticality, regulatory requirements, and business risk.


• Coordinate planned and corrective maintenance activities to minimize impact to manufacturing and laboratory operations.


• Provide technical leadership during facility failures, utility interruptions, and other critical events.


• Coordinate facility emergency response and recovery activities.


• Identify facility risks and develop appropriate mitigation and contingency strategies.


• Maintain facilities in an audit- and inspection-ready condition.

Cleanrooms & Controlled Environments

• Provide oversight of facility systems supporting classified and controlled environments.


• Ensure cleanroom HVAC and environmental control systems operate within established requirements.


• Partner with Quality and Validation to maintain appropriate environmental conditions for manufacturing and laboratory activities.


• Support cleanroom certification, environmental monitoring, and facility qualification activities.


• Investigate facility-related excursions and environmental control issues.


• Monitor trends in temperature, humidity, pressure differentials, and other critical facility parameters.


• Identify opportunities to improve cleanroom reliability, energy efficiency, environmental control, and operational performance.

HVAC, Utilities & Building Systems

Provide leadership and oversight for facility systems including:

• HVAC and air-handling systems


• Cleanroom HVAC and environmental controls


• Building Management Systems (BMS)


• Compressed air and process gases


• Electrical distribution and emergency power


• Chilled water and mechanical systems


• Temperature and humidity control systems


• Facility monitoring systems


• Fire protection and life-safety systems


• Plumbing and building infrastructure


• Manufacturing and laboratory facility support systems


• Ensure critical facility systems are appropriately maintained and remain in a state of control.


• Monitor facility-system performance and identify reliability risks before they impact manufacturing or laboratory operations.


• Coordinate troubleshooting and corrective actions for facility and utility failures.

Capital Projects & Facility Expansion

• Provide facilities leadership and technical input for capital projects and facility expansion activities.


• Participate in design reviews, constructibility reviews, FAT/SAT activities, commissioning, qualification, and startup activities.


• Ensure facility requirements are appropriately incorporated into project designs and specifications.


• Support coordination between Engineering, contractors, vendors, Validation, Quality, Manufacturing, and Facilities.


• Review Engineering Turnover Packages to ensure facility systems are complete and ready for operational ownership.


• Verify turnover documentation includes:


• Equipment and system manuals


• As-built drawings


• P&IDs


• Preventive maintenance requirements


• Spare parts recommendations


• Calibration requirements


• Vendor documentation


• Warranty information


• Qualification documentation


• Ensure newly constructed or modified facility systems are properly transitioned into Operations.

Maintenance Program Management

• Lead the development and continuous improvement of preventive and predictive maintenance programs.


• Review maintenance strategies based on equipment criticality, manufacturer recommendations, historical performance, and risk.


• Ensure maintenance activities are performed in accordance with GMP and site procedures.


• Monitor maintenance KPIs, backlog, PM compliance, equipment downtime, and recurring failures.


• Develop corrective actions for maintenance performance gaps.


• Support development of annual maintenance plans and long-term facility maintenance strategies.


• Identify opportunities to reduce unplanned downtime and improve facility reliability.

Vendor & Contractor Management

• Lead coordination of facility contractors and service providers.


• Establish expectations for contractor safety, GMP compliance, quality, documentation, and performance.


• Review contractor service reports and maintenance documentation.


• Support contractor qualification and onboarding.


• Monitor contractor performance, response times, service quality, and contractual commitments.


• Ensure contractor work is appropriately planned, controlled, and documented.


• Partner with Procurement and site leadership to evaluate vendor performance and identify opportunities for improvement.

Compliance & Documentation

• Ensure facilities activities comply with applicable:


• GMP requirements


• FDA requirements


• Applicable regulatory expectations


• Data Integrity principles


• EHS requirements


• Company procedures


• Maintain facility and maintenance documentation in an inspection-ready condition.


• Support internal audits, customer audits, and regulatory inspections.


• Serve as a facilities subject matter expert during inspections and audits.


• Participate in deviations, investigations, CAPAs, and change controls related to facility systems.


• Support Root Cause Analysis for facility and utility failures.


• Ensure facility changes are appropriately evaluated, documented, approved, and implemented.