Purpose– The Sr. Facility Engineer is responsible for ensuring the reliability, compliance, and continuous improvement of facility infrastructure and systems supporting regulated medical device manufacturing operations. This role provides technical leadership in the planning, execution, and maintenance of facility systems including HVAC, electrical, mechanical, and critical utilities. The position ensures compliance with applicable regulatory standards (e.g., Cal/OSHA, FDA) while optimizing operational efficiency, safety, and cost-effectiveness. The role serves as a key interface between engineering, EHS, quality, and external contractors.AccountabilitiesProject ManagementLead the planning, design, and execution of facility capital and expense projects including renovations, equipment installations, and infrastructure upgrades.Develop and manage project scopes, schedules, budgets, and risk assessments while ensuring compliance with regulatory, safety, and internal quality standards.Coordinate cross-functional stakeholders including Engineering, Quality, EHS, Production, and Leadership to align project objectives with operational needs.Ensure projects meet validation, commissioning, and change control requirements within the Quality Management System (QMS).Track and report project KPIs (cost, schedule adherence, performance metrics) to leadership.Technical OversightConduct engineering assessments of building systems including HVAC, compressed air, electrical distribution, plumbing, and process utilities.Ensure systems meet operational requirements, uptime expectations, and environmental controls for medical device manufacturing.Serve as the site subject matter expert (SME) for critical facility systems including HVAC, compressed air, vacuum systems, electrical distribution, chilled water, process gases, and plumbing systems.Review and approve engineering designs, drawings, and specifications to ensure compliance with operational, safety, and regulatory requirements.Ensure environmental control systems support manufacturing requirements (e.g., temperature, humidity, particulate control where applicable).Support water systems including backflow prevention, wastewater neutralization, and regulatory discharge compliance.Ensure calibration and monitoring systems are functioning correctly for regulated environments.Monitor system performance, trends, and reliability data to proactively identify degradation or failure risks.Hands-On ImplementationSupport and participate in installation, commissioning, validation, and troubleshooting of facility systems.Lead root cause investigations and corrective actions for facility-related failures or deviations impacting operations.Lead or support installation, commissioning, verification, and performance qualification of facility systems and infrastructure.Perform advanced troubleshooting of facility system failures, utilizing root cause analysis methodologies (e.g., 5-Why, Fishbone).Develop corrective and preventive actions (CAPA) for facility-related deviations impacting production or compliance.Support uptime optimization through predictive and preventative maintenance program enhancements.Maintenance & Asset ManagementOversee facility maintenance programs using CMMS systems, ensuring completion and effectiveness of preventive and corrective work orders.Develop maintenance strategies for critical assets including redundancy planning and lifecycle management.Establish and track equipment reliability metrics such as MTBF (Mean Time Between Failures) and downtime trends.Support spare parts management and critical inventory planning for essential systems.Vendor and Contractor CoordinationSelect, manage, and oversee contractors, engineers, and service providers to ensure quality work and compliance with site requirements.Ensure contractor adherence to safety programs, site procedures, and permit requirements.Source, evaluate, and manage contractors, consultants, and service providers for facility-related work.Define scopes of work (SOW), review proposals, and ensure contractors meet technical and compliance requirements.Enforce contractor safety programs, including LOTO, confined space, hot work permits, and site-specific requirements.Conduct contractor performance reviews and ensure adherence to timelines, quality standards, and regulatory obligations.Documentation and ReportingMaintain engineering documentation including drawings, specifications, maintenance records, and project files in accordance with ISO 13485 and internal QMS.Provide routine reporting on project status, facility performance metrics, and compliance activities.Maintain and control engineering documentation including:P&IDsAs-built drawingsEquipment specificationsMaintenance proceduresEnsure all facility-related changes follow formal change control processes per ISO 13485 and internal QMS.Support audit readiness by maintaining complete, accurate, and traceable documentation.Generate technical reports, deviations, and engineering justifications as required for compliance.Identify and implement cost savings and efficiency improvements, including energy reduction initiatives.Lead reliability improvement projects to reduce downtime and increase operational throughput.Support corporate sustainability initiatives, including energy usage tracking, emissions reduction, and resource conservation.Implement best practices in facility engineering and maintenance aligned with industry standards.Safety and ComplianceEnsure compliance with applicable regulations including Cal/OSHA Title 8, environmental regulations, and FDA.Support EHS programs including risk assessments, incident investigations, and safety audits related to facility systems.Innovation and Continuous ImprovementIdentify and implement improvements in facility reliability, energy efficiency, and preventative maintenance programs.Support sustainability initiatives and cost-reduction projects aligned with corporate objectives.Cross-Functional SupportProvide engineering support during audits, inspections, and regulatory reviews.Partner with Quality, Manufacturing, and EBS to support new equipment installation and process changes.Serve as technical escalation point for facility-related issues impacting production continuity or compliance.Support training initiatives and ensure personnel are trained on facility systems, safety practices, and procedures.KNOWLEDGE, SKILLS & EXPERIENCE4 year degree preferably a BS in engineering disciplines, or facility management. Minimum 5 years experience in a facility engineering role.Critical Skills/technical know-how:Advanced knowledge of facility infrastructure systems including HVAC, electrical distribution, compressed air, vacuum, plumbing, and process utilities.Ability to read, interpret, and develop:P&IDsTechnical specificationsStrong troubleshooting capability for mechanical and electrical systems, including root cause identification and system reliability improvement.Experience supporting installation, commissioning, and verification of facility systems and infrastructure.Critical Experience:Ability to read and interpret engineering drawings, schematics, and specifications.Strong project management and budgeting skills.Hands-on troubleshooting and problem-solving capability for facility systems.Experience with CMMS systems and preventative maintenance programs.Risk assessment and compliance evaluation skills.Strong communication skills for cross-functional coordination and contractor oversight.Critical Success Factors and Key ChallengesAbility to balance hands-on technical work with project management responsibilities.Maintaining regulatory compliance in a highly controlled manufacturing environment.Managing multiple concurrent projects with competing priorities and deadlines.Ensuring high system reliability with minimal downtime impacting production.Effective coordination of internal teams and external vendors.#J-18808-Ljbffr