Associate Director, Facility & Utilities Engineering Lead

Associate Director, Facility & Utilities Engineering Lead

Merck is seeking an Associate Director, Facility & Utilities Engineering Lead to support the Next Generation Biologics (NGB) facility at the Rahway, NJ headquarters.

The Biologics Process Research & Development organization within our Research Labs is responsible for developing the drug substance manufacturing processes for our biologics pipeline. We collaborate with Discovery, Pre‑clinical, and Early Development to rapidly develop processes for diverse biotherapeutics, and efficiently produce material for clinical trials. We also lead commercial process development, technology implementation, and work with Manufacturing to commercialize and launch new products.

This role will support the NGB facility—a premier, state‑of‑the‑art GMP facility designed for multi‑product operations with flexible operating suites.

• Lead the Facility & Utilities Engineering team to provide 24/7/365 building support for critical GMP operations.
• Manage process & facilities equipment, and utilities (clean and grey) maintenance and calibration.
• Maintain redundancy through training for operation, metrology, maintenance, etc. to provide off‑hours, weekend and holiday coverage.
• Ensure accountability is delivered in accordance with EHS regulatory and company EHS requirements.
• Build robust communication channels with site support teams (utilities, etc.) and NGB operations to coordinate planned and unplanned activities, annual shutdowns, and maintain robust building operations.
• Manage and provide oversight to outsource service providers, such as equipment service providers, GMP area cleaning, etc.
• Drive continuous improvement programme across all areas – safety, environmental management, quality compliance, equipment reliability and uptime, efficiency and operational excellence.
• Manage a team, including hiring, building capabilities, performance management and providing leadership and personnel development strategies.
• Support facility and utilities assessment for New Product Introduction as required.
• Support Energy Management, Environmental Sustainability & Business Continuity activities through data analysis.
• Accountable for delivery of Engineering spend within approved budget.
• Investigate equipment failures or area deviations to find root cause and implement effective Corrective and Preventative Actions (CAPA).
• Conduct life‑cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan.
• Serve as a technical mentor and help train rotational and new employees, supervise staff performing GMP activities and deliver training as needed.

Required Education,

Experience and Skills:

Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with a minimum of 8 years relevant experience, or a Master’s degree with a minimum of 6 years relevant experience.

Experience &

Skills:

• Demonstrated experience (8+ years) in a GMP‑regulated biological drug substance manufacturing environment, ideally with single‑use systems.
• Prior team‑management experience and monitoring performance.
• Deep understanding of facilities and engineering management in a GMP environment with detailed knowledge of clean utilities systems.
• Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), and Safety for operations.
• Ability to perform technical analysis to drive continuous improvement and overall efficiency.

• Culture building:
  Establish a high‑performance culture that promotes innovation, diversity, and inclusion.
• Track record of working effectively with team members of diverse skill sets and backgrounds.
• Excellent troubleshooting and problem‑solving skills.
• Capability to apply Delta V and MES (Manufacturing Execution System) knowledge.
• Strong verbal and written communication skills, attention to detail.
• Experience with GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to engineering.
• Self‑motivation, continuous…