Senior GMP Facility & Utilities Engineer

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

Benefits offered by this job

Medical

Dental

Vision

Insurance benefits

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks an experienced specialist to operate the Next Generation Biologics facility, supporting GMP operations for a multi-product, flexible suite. The role covers equipment qualification, start-up activities, and 24/7 facility support, with emphasis on safety and regulatory compliance.

The candidate should have a strong background in GMP utilities, DeltaV control, and CMMS/CCMS systems, with the ability to train staff and lead continuous improvement initiatives.

Qualifications

• Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 5 years relevant experience.
• A Master’s degree with minimum 3 years of relevant experience.

Responsibilities

• Act as an SME for operation of facility & utilities equipment; prepare/review user requirements.
• Support equipment maintenance, calibration, and utilities (clean and grey).
• Be an active member of Facility & Utilities Engineering for 24/7 support of GMP operations.
• Assist start-up activities including equipment qualification, training curricula, and CMMS implementation.
• Support readiness activities for launch of the new GMP facility.
• Manage vendors and contractors during maintenance and calibration of process equipment.
• Provide timely feedback and foster a culture of trust for open dialogue.
• Train technicians in technical, compliance, safety, and environmental procedures; write SOPs.

Skills

GMP

Capital project mgmt

Competency mgmt

Data analysis

Deviation management

Employee training

Equipment installations

Equipment maintenance

Equipment management

Microsoft Project

Procedure writing

Process Hazard Analysis

Root Cause Analysis

Education

Bachelor’s degree

Master’s degree

Tools

CMMS

CCMS

DeltaV

MES

SAP

Job description

Merck & Co., Inc. in Rahway, NJ, seeks an experienced specialist to operate the Next Generation Biologics facility, supporting GMP operations for a multi-product, flexible suite. The role covers equipment qualification, start-up activities, and 24/7 facility support, with emphasis on safety and regulatory compliance.

The candidate should have a strong background in GMP utilities, DeltaV control, and CMMS/CCMS systems, with the ability to train staff and lead continuous improvement initiatives.