Facilities Lead Job Raleigh area,North Carolina USA,Maintenance/Cleaning

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, clean rooms, 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.

Clean rooms & 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…