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.

The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.

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