Associate Director, Maintenance, Utilities, & Engineering

Merck•Wilmington, DE

20h•Hybrid

About The Position

The Associate Director, Maintenance provides operational leadership and technical oversight of maintenance activities for the sterile product manufacturing site. In this role, the Associate Director ensures equipment reliability, safe work practices, and regulatory compliance while supporting production needs and continuous improvement initiatives. In addition, this role will support the development and execution of the site’s Integrated Facilities Management (IFM) strategy and will actively participate throughout the project life cycle in Factory Acceptance Tests (FATs) for utilities, facilities, and process equipment to ensure maintainability, reliability, and lifecycle considerations are incorporated into equipment and system design.

Requirements

Bachelor’s degree in Engineering, Facilities Management, or a related technical field with
Seven (7) years of maintenance experience in pharmaceutical or biotech manufacturing; sterile manufacturing experience strongly preferred.
At least three (3) years in a supervisory or team-lead role with responsibility for maintenance technicians or supervisors.
Practical experience with CMMS, preventive maintenance, and predictive maintenance programs.
Familiarity with GMP, safety regulations, and industry standards applicable to sterile manufacturing.
Proven experience troubleshooting process equipment and coordinating corrective actions with cross-functional teams.
Working knowledge of Lean principles or continuous improvement methods.
Strong communication skills and ability to collaborate across production, quality, engineering, and facilities teams.

Nice To Haves

Experience with potent compound manufacturing
Experience supporting or interfacing with Integrated Facilities Management (IFM) organizations.
Experience participating in or supporting FATs, SATs, and equipment qualification activities.
Exposure to predictive maintenance technologies (vibration analysis, ultrasound, thermography) or coordination with Predictive Maintenance (PdM) service providers.
Demonstrated ability to develop, coach, and retain maintenance technicians.

Responsibilities

Capital Projects & Equipment Lifecycle Support
Participate as the maintenance representative in major capital project design, execution, and start-up, with primary emphasis on start-up readiness—ensuring maintenance strategies, CMMS build-out, spare parts, diagnostic capabilities, SOPs, training, and reliable systems turnover are fully in place prior to qualification and initial manufacturing—along with participation in future capital equipment installations and small- to mid-scale upgrade projects, coordinating contractors and internal resources under engineering or project management leadership.
Attend and actively participate in utility, facility, and process equipment Factory Acceptance Tests (FATs) throughout the project life cycle.
Provide maintenance and reliability input during FATs to ensure:
Maintainability and accessibility are considered
Spare parts strategies are optimized
Standardization, diagnostics, and serviceability are aligned with site practices
Support equipment turnover to maintenance, including documentation review, CMMS asset setup, and maintenance strategy development.
Maintenance Operations & Leadership
Oversee day-to-day maintenance operations for assigned production areas, including preventive, predictive, and corrective maintenance activities.
Supervise, coach, and develop maintenance staff; ensure adherence to safe work practices and OSHA/GMP requirements.
Coordinate maintenance priorities with production, quality, and engineering teams to minimize downtime and support production schedules.
Ensure accurate and timely execution and documentation of maintenance activities within the CMMS.
Maintain key maintenance performance metrics for assigned areas and communicate operational status to site leadership.
Integrated Facilities Management (IFM) Support
Support the development, deployment, and ongoing execution of the site IFM strategy in alignment with site leadership objectives.
Serve as a key maintenance interface with IFM service providers, ensuring alignment with maintenance standards, safety expectations, and GMP requirements.
Participate in defining maintenance scopes of work, service-level expectations, and performance metrics related to IFM services.
Support monitoring of IFM performance and identification of continuous improvement opportunities at the operational level.
Reliability & Continuous Improvement
Implement and sustain preventive and predictive maintenance tasks as defined by site strategy and reliability programs.
Support troubleshooting and root-cause analysis for major equipment or system failures; coordinate corrective actions with engineering and subject-matter experts.
Apply Lean and continuous improvement principles at the area or equipment level to reduce downtime and improve maintenance efficiency.
Support reliability improvement initiatives by providing operational insights on equipment performance and maintainability.
Compliance & Regulatory Readiness
Ensure all maintenance activities comply with GMP requirements, safety regulations, and site procedures.
Prepare, maintain, and provide maintenance records and documentation to support internal reviews and regulatory inspections.
Support inspection readiness activities by ensuring assigned areas meet compliance and documentation expectations.