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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 Support, and Business Continuity

• Lead maintenance planning and execution for site shutdowns, turnarounds, utility outages, equipment interventions, and major preventive-maintenance campaigns.

• Develop integrated shutdown schedules, resource plans, contractor strategies, parts readiness, risk controls, and contingency plans.

• Coordinate maintenance support during commissioning, qualification, engineering runs, process validation, and startup activities.

• Establish emergency maintenance response and business-continuity plans for critical equipment and utility failures.

• Participate in site emergency response, incident command, and recovery activities as required.

• Conduct post-event reviews and implement lessons learned to improve future shutdown and outage performance.

Capital Projects, CQV, and Operational Handover

• Represent Maintenance in capital project design reviews, constructability and maintainability assessments, equipment selection, and lifecycle-cost decisions.

• Provide maintenance input to user requirements, design specifications, equipment standards, access requirements, lifting and handling provisions, and serviceability expectations.

• Participate in FAT, SAT, commissioning, qualification, and startup activities to ensure equipment is maintainable and ready for operational ownership.

• Define and track maintenance deliverables within project turnover packages, including manuals, drawings, parts lists, training, warranties, job plans, and CMMS data.

• Ensure deficiencies affecting safe maintenance, reliability, or lifecycle support are resolved before final handover.

• Support capital planning for equipment replacement, reliability improvements, maintenance infrastructure, and lifecycle-risk reduction.

Safety, Operational Excellence, and Performance Management

• Promote a strong safety culture and ensure maintenance work complies with lockout/tagout, electrical safety, confined-space, hot-work, line-break, work-at-height, and permit-to-work requirements.

• Lead continuous-improvement initiatives using Lean, problem-solving, and operational-excellence methodologies.

• Develop and manage maintenance KPIs, including safety, preventive-maintenance compliance, schedule compliance, backlog, downtime, mean time between failures, mean time to repair, work-order quality, labor productivity, and maintenance cost.

• Establish tiered performance reviews and visual-management routines to identify risks, prioritize actions, and sustain accountability.

• Develop and manage the maintenance operating budget, contractor spend, tooling requirements, and resource forecasts.

• Identify opportunities to improve asset reliability, reduce unplanned downtime, optimize maintenance costs, and increase workforce effectiveness.

Cross-Functional Collaboration

• Partner with Manufacturing, Utilities Operations, Engineering, Reliability, Facilities, Automation, Validation, Metrology, Quality, EHSS, Supply Chain, Procurement, Capital Projects, Global Engineering, and external service providers.

• Coordinate maintenance priorities and equipment availability with production and utility operating plans.

• Build effective interfaces among maintenance, engineering system owners, reliability engineers, and operations teams.

• Communicate equipment risks, backlog constraints, shutdown needs, resource requirements, and recovery plans clearly to site leadership.

• Represent Maintenance in site governance forums, project reviews, readiness assessments, and operational performance meetings.

People Leadership

• Lead, mentor, and develop a high-performing, diverse maintenance organization.

• Set clear performance expectations and promote accountability, collaboration, inclusion, and continuous learning.

• Develop technical qualification and progression pathways for maintenance supervisors, planners, schedulers, and technicians.

• Ensure contractors and contingent workers meet site expectations for safety, quality, technical competency, and performance.

• Create a culture of disciplined execution, problem solving, ownership, and reliable service to internal customers.

Basic Qualifications

• Bachelor's degree in Engineering, Maintenance Management, or a related technical discipline.

• 10+ years of maintenance, engineering, reliability, or operations experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing.

• 5+ years of people-leadership experience within maintenance, engineering, or technical operations.

• Demonstrated experience leading maintenance work-management processes and multidisciplinary technical teams.

Preferred Qualifications

• Experience developing or leading maintenance programs for a greenfield pharmaceutical or biologics manufacturing facility.

• Experience supporting commissioning, qualification, startup, process validation, and operational handover.

• Strong knowledge of CMMS implementation and master data, asset hierarchy, preventive-maintenance development, planning and scheduling, and spare-parts management.

• Experience with critical GMP utilities, central utility buildings, electrical distribution, HVAC, automation, and manufacturing-support systems.

• Knowledge of reliability-centered maintenance, predictive technologies, root-cause analysis, Lean, and operational-excellence tools.

• Experience managing maintenance contractors, service agreements, operating budgets, and shutdown execution.

• Knowledge of cGMP, data integrity, OSHA requirements, NFPA 70E, lockout/tagout, and applicable regulatory expectations.

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