Greenfield Facility Engineer: Cleanroom & Utilities Lead

Serovia; Branchburg Township (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Serovia in Branchburg, NJ is advancing a greenfield sterile injectable IV bag facility. The Facility Engineer will lead design, startup, and long-term operation of infrastructure including cleanrooms, HVAC, utilities, building automation, environmental monitoring, and energy management to ensure cGMP compliance.

The role requires collaboration with Validation, Quality, and Operations to qualify the facility (IQ/OQ/PQ) and maintain readiness for inspections.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Industrial, or Facilities Engineering.
• 5+ years in pharmaceutical or sterile manufacturing facility engineering.
• Strong knowledge of HVAC, cleanrooms, and critical utilities.
• Experience with greenfield facilities construction, commissioning, and qualification.
• Familiarity with FDA cGMP, USP, and EH&S requirements.

Responsibilities

• Lead design review, specification development, and technical oversight of facility infrastructure systems (cleanrooms, HVAC, utilities).
• Develop and maintain facility engineering standards, equipment specifications, and regulatory-aligned documentation.
• Oversee construction, installation, commissioning, and qualification of facility utilities.
• Collaborate with Validation, Quality, and Operations for IQ/OQ/PQ and environmental monitoring readiness.
• Promote safety protocols and safe work practices.
• Perform risk assessments for engineering and maintenance activities.
• Establish and manage preventative maintenance programs and SOPs.
• Provide technical troubleshooting for facility system deviations and CAPAs.
• Coordinate with EHS, Operations, and Quality to meet regulatory expectations.
• Manage relationships with external engineering firms and contractors.
• Support energy management and continuous improvement initiatives.

Skills

Project management

Contractor/vendor coordination

Problem solving

Cross-functional collaboration

Attention to safety/compliance

Education

Bachelor’s degree in Mechanical/Electrical/Industrial/Facilities Engineering

Job description

Serovia in Branchburg, NJ is advancing a greenfield sterile injectable IV bag facility. The Facility Engineer will lead design, startup, and long-term operation of infrastructure including cleanrooms, HVAC, utilities, building automation, environmental monitoring, and energy management to ensure cGMP compliance.

The role requires collaboration with Validation, Quality, and Operations to qualify the facility (IQ/OQ/PQ) and maintain readiness for inspections.