Senior GMP Facilities & Utilities Operations Engineer

HireLifeScience; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) plan

Paid holidays

Vacation

Sick leave

Job summary

Merck in Rahway, NJ, seeks an experienced engineer to operate and supervise a Biologics GMP facility, focusing on utilities and process equipment for drug substance manufacturing. The role supports startup activities, equipment qualification, and ongoing calibration and maintenance to ensure compliance and readiness for clinical trial supply.

You will mentor junior staff, train teams in safety, compliance, and technical SOPs, and collaborate across the network to promote operational consistency

Qualifications

• 3+ years of experience in a GMP-regulated clean utilities systems, biologics drug substance manufacturing equipment.
• Familiar with HVAC, cold rooms and temperature control units (TCU).
• Working knowledge of Computerized Maintenance Management System (CMMS) & Computerized Calibration Management System (CCMS).
• Strong understanding of GMP manufacturing environments, including upstream and downstream processing equipment.

Responsibilities

• Act as an SME for operation of innovative facility & utilities equipment, preparing/reviewing user requirements.
• Support process & facilities equipment, and utilities (clean and grey) maintenance and calibration.
• Active member of Facility & Utilities Engineering team to ensure 24/7/365 building support for critical GMP operations.
• Support start-up activities including equipment qualification, training curricula, staff training, and CMMS implementation.
• Support operational readiness activities for launch of the new GMP facility.
• Manage vendor and contractors during maintenance and calibration of process equipment.
• Provide timely performance feedback and foster culture of trust for open dialogue.
• Coach Junior team members in development planning for soft and technical skills.

Skills

Building Capability

Capital Project Management

Competency Management

Data Analysis

Deviation Management

Employee Training

Equipment Installations

Equipment Maintenance

Equipment Management

GMP

Microsoft Project

Operation Maintenance

Procedure Writing

Process Hazard Analysis

Root Cause Analysis

Education

Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline

Master's degree with minimum 3 years of relevant experience

Tools

CMMS

CCMS

DeltaV

MES

SAP

Veeva Quality Docs

Job description

Merck in Rahway, NJ, seeks an experienced engineer to operate and supervise a Biologics GMP facility, focusing on utilities and process equipment for drug substance manufacturing. The role supports startup activities, equipment qualification, and ongoing calibration and maintenance to ensure compliance and readiness for clinical trial supply.

You will mentor junior staff, train teams in safety, compliance, and technical SOPs, and collaborate across the network to promote operational consistency