Associate Director, Maintenance

Job description

Job Description Associate Director, Maintenance – Wilmington Biologics Site Position Summary The Associate Director, Maintenance provides strategic and operational leadership for the development, implementation, and execution of the maintenance program supporting the Wilmington biologics manufacturing campus. This role is accountable for ensuring that facility, utility, laboratory, warehouse, and manufacturing-support assets are maintained safely, reliably, compliantly, and efficiently to enable startup, qualification, commercial readiness, and sustained operations. Reporting to the Director of Engineering, Maintenance & Utilities (EMU), the Associate Director builds and leads the site maintenance organization, including maintenance leaders, planners and schedulers, skilled technicians, and supporting contractors. The role establishes the maintenance operating model, work-management processes, asset and preventive-maintenance data, spare-parts strategy, performance metrics, and governance required for a greenfield biologics facility. This leader partners closely with Engineering, Reliability, Facilities, Manufacturing, Quality, Validation, Automation, Metrology, EHSS, Supply Chain, Capital Projects, and Global Engineering to ensure an effective transition from design and construction through commissioning, qualification, startup, and routine GMP operations. Maintenance Leadership and Organizational Development Provide strategic leadership, technical direction, and coaching to the site maintenance organization supporting the Wilmington campus. Design, build, and scale the maintenance organization to meet phased facility startup and commercial manufacturing requirements. Lead maintenance first-line managers, planners and schedulers, mechanical and electrical technicians, instrumentation support, and contracted maintenance resources. Establish clear roles, decision rights, escalation pathways, shift coverage, and on-call support for safe and reliable operations. Build organizational capability through recruiting, onboarding, qualification, technical training, succession planning, and employee development. Greenfield Maintenance Program and Operational Readiness Develop and implement the site maintenance strategy, governance model, procedures, standards, and business processes for a new biologics manufacturing facility. Create the maintenance readiness plan aligned with building completion, equipment turnover, commissioning and qualification, engineering runs, process validation, and commercial startup. Ensure maintenance requirements are incorporated into equipment design reviews, maintainability assessments, vendor packages, FATs, SATs, commissioning activities, and operational handover. Establish asset acceptance criteria and verify that technical documentation, recommended spare parts, maintenance instructions, warranties, training, and vendor support are complete before ownership transfer. Coordinate phased deployment of maintenance staffing, tools, shops, service contracts, and support infrastructure as the campus becomes operational. Maintenance Operations and Work Management Own the site maintenance work-management process, including work identification, prioritization, planning, scheduling, execution, closeout, and performance review. Establish preventive, predictive, condition-based, corrective, emergency, and shutdown maintenance workflows consistent with cGMP and site procedures. Lead daily and weekly maintenance planning and scheduling routines in coordination with Manufacturing, Utilities Operations, Facilities, Quality, and Supply Chain. Ensure maintenance work is executed with appropriate job plans, permits, risk assessments, lockout/tagout controls, parts, tools, labor estimates, and quality documentation. Develop effective 24/7 response and escalation processes for critical equipment, utility, facility, and infrastructure failures. Drive schedule compliance, backlog health, wrench time, first-time quality, and timely closure of maintenance records. Asset Reliability and Lifecycle Management Partner with Reliability Engineering and system owners to develop asset criticality rankings, maintenance strategies, and lifecycle plans Implement reliability-centered maintenance, predictive maintenance, and condition-monitoring technologies based on equipment risk and failure modes. Lead or support equipment investigations, root-cause analyses, FMEAs, bad-actor elimination, and corrective and preventive actions. Use performance and failure data to optimize maintenance frequencies, job plans, spare-parts holdings, and asset replacement strategies. Ensure maintenance strategies support critical GMP utilities and infrastructure, including WFI, Purified Water, Clean Steam, process gases, HVAC, chilled water, steam, compressed air, electrical distribution, emergency power, UPS, refrigeration, and wastewater interfaces. Support reliable operation of manufacturing-support, laboratory, warehouse, and building systems across the Wilmington campus. CMMS, Maintenance Data, and Digital Systems Serve as the business owner for maintenance processes within the computerized maintenance management system (CMMS). Establish the asset hierarchy, equipment records, functional locations, maintenance plans, task lists, job plans, bills of materials, labor standards, and master-data governance required for startup. Ensure maintenance master data is accurate, complete, controlled, and aligned with engineering drawings, turnover packages, equipment tags, and the qualified state. Define user roles, workflows, reporting, and data-quality expectations for planners, supervisors, technicians, engineers, and contractors. Leverage digital tools, mobile execution, dashboards, and analytics to improve maintenance productivity, compliance, and equipment performance. Partner with Automation, IT, Engineering, and Reliability to integrate condition-monitoring and asset-performance information where appropriate. Spare Parts, Materials, and Vendor Management Develop and implement the site spare-parts and maintenance-materials strategy, including critical spares, insurance spares, consumables, repairables, and vendor-managed inventory. Establish spare-parts criticality, stocking levels, preservation requirements, storage conditions, cycle counting, obsolescence management, and replenishment processes. Ensure bills of materials and equipment-to-spare relationships are established in the CMMS and aligned with manufacturer recommendations and reliability risk. Partner with Supply Chain, Procurement, Engineering, and Logistics to establish storeroom operations and material availability for planned and emergency work. Develop and govern maintenance service contracts, vendor scopes, performance expectations, safety requirements, quality agreements where applicable, and service-level metrics. Manage original equipment manufacturer and specialty contractor support during startup and routine operations. Compliance and Inspection Readiness Ensure maintenance activities comply with cGMP, FDA, EMA, OSHA, EPA, company quality standards, site procedures, and applicable engineering codes. Maintain inspection readiness for maintenance records, preventive-maintenance execution, equipment history, work-order documentation, deviations, CAPAs, change controls, and contractor activities. Ensure maintenance is performed without compromising validated systems, product quality, data integrity, environmental controls, or the qualified state. Establish maintenance documentation standards and right-first-time expectations for work-order completion and technical records. Support internal audits, health authority inspections, quality reviews, and responses to maintenance-related observations. Partner with Quality, Validation, Metrology, and system owners to coordinate post-maintenance testing, calibration, return-to-service, and release requirements. Shutdowns, Startup S