Process & Facility Engineer, MACS Scaleup

MSD Malaysia; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical, dental, vision healthcare

Retirement benefits (401(k))

Paid holidays

Vacation

Relocation assistance available

Job summary

Merck in Rahway, NJ is seeking a Specialist – Process/Facility Engineering to help establish the MACS Center during start-up and qualification activities, with GMP manufacturing experience. You will contribute to equipment design, system commissioning, qualification, and collaborate with Process R&D, QA, and Safety to ensure compliant, scalable manufacturing.

This role supports facility operations and cross-functional processes toward a 2Q 2027 target.

Qualifications

• Working in a GMP clinical or manufacturing supply facility.
• GMP facility design, equipment start-up and/or qualification.
• Small and/or large molecule drug substance process development.
• Supporting compliance investigations and change management.
• Familiarity with US and EU GMP and Safety compliance regulations.
• Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills to multi-task.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

Responsibilities

• Set up the MACS Center by contributing to equipment and facility design, system commissioning and qualification.
• Collaborate with development engineers, chemists, QA, safety and other teams to ensure quality and compliant clinical supplies.
• Support facility startup and subsequent batch processing across multi-modality drug substances.
• Lead or participate in enabling facilities and related workstreams to accelerate scale-up.

Skills

GMP facility operations

Process engineering

Facility engineering

SOP development

cGMP documentation

Cross-functional collaboration

Education

Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related field

Master’s degree with 1 year of relevant experience

Tools

GMP regulations

Process qualification

Job description

Merck in Rahway, NJ is seeking a Specialist – Process/Facility Engineering to help establish the MACS Center during start-up and qualification activities, with GMP manufacturing experience. You will contribute to equipment design, system commissioning, qualification, and collaborate with Process R&D, QA, and Safety to ensure compliant, scalable manufacturing.

This role supports facility operations and cross-functional processes toward a 2Q 2027 target.