Senior Engineer, GMP Facility Operations & Utilities

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

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Sr. Engineer, Facility Operations to support the NGB facility buildout and 24/7 GMP operations.

You will collaborate with Facility & Utilities Engineering to ensure readiness, qualification and ongoing maintenance of critical process equipment and utilities. The role requires deep knowledge of cGMP, EHS, and calibration programs, with hands-on training for technicians and a proven ability to lead cross-functional teams in a fast-paced biopharma

Qualifications

• Minimum 5 years of relevant GMP-regulated clean utilities systems experience.
• Strong knowledge of HVAC, cold rooms, and temperature control units.
• Experience with CMMS/CCMS and GMP manufacturing environments.
• Knowledge of EHS requirements and quality systems.

Responsibilities

• Serve as SME for operation of facility & utilities equipment; prepare/review user requirements.
• Support maintenance and calibration of process equipment and utilities.
• Ensure 24/7 building support for critical GMP operations.
• Assist start-up activities: equipment qualification, training curricula, staff training, CMMS implementation.
• Support readiness for launch of the new GMP facility.
• Oversee vendor/contractor activities during maintenance and calibration.
• Provide feedback and foster a culture of trust; coach junior team members.
• Train technicians on technical, compliance, safety, and environmental procedures; write SOPs.

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

DeltaV

CMMS

CCMS

SAP

MES

Microsoft Office

Education

Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 5 years relevant experience

Master’s degree with minimum 3 years relevant experience

Tools

DeltaV

CMMS

CCMS

SAP

MES

Microsoft Office

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a Sr. Engineer, Facility Operations to support the NGB facility buildout and 24/7 GMP operations.

You will collaborate with Facility & Utilities Engineering to ensure readiness, qualification and ongoing maintenance of critical process equipment and utilities. The role requires deep knowledge of cGMP, EHS, and calibration programs, with hands-on training for technicians and a proven ability to lead cross-functional teams in a fast-paced biopharma