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Senior Engineer, Facility & Utilities Operations (On-site)

$117k - $184.2k

Merck

Merck seeks a Senior Engineer for Facility & Utilities Operations to support a next-generation biologics GMP facility in Rahway, New Jersey. The role involves equipment expertise, facilities maintenance oversight, regulatory compliance, and leadership of operational readiness activities for a state-of-the-art multi-product manufacturing facility.

Responsibilities

  • Serve as subject matter expert for innovative facility and utilities equipment operation and user requirements
  • Support process equipment, utilities maintenance, and calibration to ensure 24/7/365 building support for critical operations
  • Lead facility and utilities planning, vendor management, and support equipment qualification and startup activities
  • Drive cGMP and EHS compliance, write and approve SOPs, troubleshoot technical issues, and initiate deviation management
  • Coach junior team members, provide on-call support, and collaborate across the network to promote operational consistency

Requirements

  • Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, or related discipline with 5+ years relevant experience
  • 3+ years experience in GMP-regulated clean utilities systems and biologics drug substance manufacturing equipment
  • Knowledge of HVAC, cold rooms, temperature control units, CMMS, and CCMS systems
  • Strong understanding of GMP environments, upstream and downstream processing, cGMP, and EHS requirements
  • Experience writing SOPs and technical documents; ability to train employees in technical, compliance, and safety procedures
  • Proficiency with DeltaV, Microsoft Office, and project management software; strong troubleshooting and decision-making skills
Vacancy posted 4 days ago
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