Facilities Lead
hace 4 días
Raleigh
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.