Associate Director, Maintenance, Utilities, & Engineering
Merck
5 hours ago
On-site
Wilmington, DE
Operations
Associate Director, Maintenance provides operational leadership and technical oversight of maintenance activities for the sterile product manufacturing site. Ensures equipment reliability, safe work practices, and regulatory compliance while supporting production needs and continuous improvement.
Key Responsibilities
- Capital Projects & Equipment Lifecycle Support
- Serve as maintenance representative for major capital project design, execution, and start-up with a focus on start-up readiness (maintenance strategies, CMMS build-out, spare parts, diagnostics, SOPs, training, and reliable systems turnover prior to qualification and initial manufacturing), and support future installations and small- to mid-scale upgrades.
- Participate in utility, facility, and process equipment Factory Acceptance Tests (FATs) throughout the project life cycle.
- Provide maintenance/reliability input during FATs: ensure maintainability/accessibility, optimize spare parts strategy, align standardization/diagnostics/serviceability with site practices.
- Support equipment turnover to maintenance (documentation review, CMMS asset setup, and maintenance strategy development).
- Maintenance Operations & Leadership
- Oversee day-to-day maintenance operations for assigned production areas (preventive, predictive, corrective maintenance).
- Supervise, coach, and develop maintenance staff; ensure OSHA/GMP safe work practices.
- Coordinate maintenance priorities with production, quality, and engineering to minimize downtime.
- Ensure timely CMMS execution and documentation; maintain maintenance performance metrics and communicate status to site leadership.
- Integrated Facilities Management (IFM) Support
- Support development and ongoing execution of the site IFM strategy.
- Interface with IFM service providers to align maintenance standards, safety expectations, and GMP requirements.
- Define IFM maintenance scopes, service-level expectations, and performance metrics; monitor performance and identify continuous improvement opportunities.
- Reliability & Continuous Improvement
- Implement preventive and predictive maintenance tasks per site strategy and reliability programs.
- Support troubleshooting and root-cause analysis for major failures; coordinate corrective actions with engineering and SMEs.
- Apply Lean/continuous improvement to reduce downtime and improve maintenance efficiency.
- Provide operational insights to support reliability improvements.
- Compliance & Regulatory Readiness
- Ensure maintenance activities comply with GMP, safety regulations, and site procedures.
- Maintain maintenance records/documentation for internal reviews and regulatory inspections; support inspection readiness.
Qualifications
Required
- Bachelor’s degree in Engineering, Facilities Management, or related technical field.
- 7 years of maintenance experience in pharmaceutical/biotech manufacturing; sterile manufacturing strongly preferred.
- 3+ years in a supervisory/team-lead role managing maintenance technicians/supervisors.
- Experience with CMMS, preventive maintenance, and predictive maintenance programs.
- Familiarity with GMP, safety regulations, and sterile manufacturing industry standards.
- Proven experience troubleshooting process equipment and coordinating corrective actions with cross-functional teams.
- Working knowledge of Lean or continuous improvement methods.
- Strong communication and collaboration across production, quality, engineering, and facilities.
Preferred
- Experience with potent compound manufacturing.
- Experience interfacing with Integrated Facilities Management (IFM) organizations.
- Experience supporting FATs/SATs and equipment qualification activities.
- Exposure to predictive maintenance technologies (vibration analysis, ultrasound, thermography) or coordination with PdM providers.
- Demonstrated ability to develop, coach, and retain maintenance technicians.
Required Skills
Adaptability; Capital Projects; Computerized Maintenance Management Systems (CMMS); Corrective Action Management; Corrective Maintenance; Digital Transformation; Documentation Review; Driving Continuous Improvement; Facility Management; GMP Compliance; HVAC Systems; Maintenance Documentation; Maintenance Management; Maintenance Strategy; Occupational Health and Safety Management; People Leadership; Predictive Maintenance; Preventive/Preventative Maintenance Programs; Preventive Action; Process Control Systems; Regulatory Compliance; Reliability Engineering; Safety Leadership; Technical Writing
Key Responsibilities
- Capital Projects & Equipment Lifecycle Support
- Serve as maintenance representative for major capital project design, execution, and start-up with a focus on start-up readiness (maintenance strategies, CMMS build-out, spare parts, diagnostics, SOPs, training, and reliable systems turnover prior to qualification and initial manufacturing), and support future installations and small- to mid-scale upgrades.
- Participate in utility, facility, and process equipment Factory Acceptance Tests (FATs) throughout the project life cycle.
- Provide maintenance/reliability input during FATs: ensure maintainability/accessibility, optimize spare parts strategy, align standardization/diagnostics/serviceability with site practices.
- Support equipment turnover to maintenance (documentation review, CMMS asset setup, and maintenance strategy development).
- Maintenance Operations & Leadership
- Oversee day-to-day maintenance operations for assigned production areas (preventive, predictive, corrective maintenance).
- Supervise, coach, and develop maintenance staff; ensure OSHA/GMP safe work practices.
- Coordinate maintenance priorities with production, quality, and engineering to minimize downtime.
- Ensure timely CMMS execution and documentation; maintain maintenance performance metrics and communicate status to site leadership.
- Integrated Facilities Management (IFM) Support
- Support development and ongoing execution of the site IFM strategy.
- Interface with IFM service providers to align maintenance standards, safety expectations, and GMP requirements.
- Define IFM maintenance scopes, service-level expectations, and performance metrics; monitor performance and identify continuous improvement opportunities.
- Reliability & Continuous Improvement
- Implement preventive and predictive maintenance tasks per site strategy and reliability programs.
- Support troubleshooting and root-cause analysis for major failures; coordinate corrective actions with engineering and SMEs.
- Apply Lean/continuous improvement to reduce downtime and improve maintenance efficiency.
- Provide operational insights to support reliability improvements.
- Compliance & Regulatory Readiness
- Ensure maintenance activities comply with GMP, safety regulations, and site procedures.
- Maintain maintenance records/documentation for internal reviews and regulatory inspections; support inspection readiness.
Qualifications
Required
- Bachelor’s degree in Engineering, Facilities Management, or related technical field.
- 7 years of maintenance experience in pharmaceutical/biotech manufacturing; sterile manufacturing strongly preferred.
- 3+ years in a supervisory/team-lead role managing maintenance technicians/supervisors.
- Experience with CMMS, preventive maintenance, and predictive maintenance programs.
- Familiarity with GMP, safety regulations, and sterile manufacturing industry standards.
- Proven experience troubleshooting process equipment and coordinating corrective actions with cross-functional teams.
- Working knowledge of Lean or continuous improvement methods.
- Strong communication and collaboration across production, quality, engineering, and facilities.
Preferred
- Experience with potent compound manufacturing.
- Experience interfacing with Integrated Facilities Management (IFM) organizations.
- Experience supporting FATs/SATs and equipment qualification activities.
- Exposure to predictive maintenance technologies (vibration analysis, ultrasound, thermography) or coordination with PdM providers.
- Demonstrated ability to develop, coach, and retain maintenance technicians.
Required Skills
Adaptability; Capital Projects; Computerized Maintenance Management Systems (CMMS); Corrective Action Management; Corrective Maintenance; Digital Transformation; Documentation Review; Driving Continuous Improvement; Facility Management; GMP Compliance; HVAC Systems; Maintenance Documentation; Maintenance Management; Maintenance Strategy; Occupational Health and Safety Management; People Leadership; Predictive Maintenance; Preventive/Preventative Maintenance Programs; Preventive Action; Process Control Systems; Regulatory Compliance; Reliability Engineering; Safety Leadership; Technical Writing