On-the-Floor Process Engineer — Clinical Supply GMP

Merck; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck & Co. in Rahway, NJ, is seeking an Associate Specialist – Process Engineer to lead clinical supply manufacturing in a GMP piloting facility.

You will manage on-the-floor batch production, ensure safety and quality, and draft batch records, change controls, and related documentation. The role requires experience with pilot plant manufacturing, electronic batch records, and MES systems, plus knowledge of drug product processing.

Qualifications

• Experience executing GxP manufacturing in pilot plant environment.
• Experience supporting electronic batch records and MES systems.
• Knowledge and experience of drug product processing.
• Willingness to learn and contribute through independent problem-solving.
• Experience leading and supporting quality investigations and change management.

Responsibilities

• Lead on-the-floor batch manufacturing to ensure safety and quality of clinical supplies.
• Draft and execute GxP documentation including batch records, equipment qualification and cleaning, change records and deviations.
• Build partnerships by developing relationships within and across work groups of formulators, engineers, safety and quality representatives.
• Foster culture of collaboration, learning and innovation.

Skills

Continuous Improvement

Engineering Standards

Equipment Qualification

GMP Compliance

GMP Validation

Lean Manufacturing

Process Control

Process Optimization

Teamwork

Education

Associate's degree in chemical engineering or related field

Bachelor's degree in chemical engineering, chemistry, pharmaceutical sciences, or related

Master's degree in chemical engineering, chemistry, pharmaceutical sciences, or related

Tools

Electronic batch records

MES systems

Job description

Merck & Co. in Rahway, NJ, is seeking an Associate Specialist – Process Engineer to lead clinical supply manufacturing in a GMP piloting facility.

You will manage on-the-floor batch production, ensure safety and quality, and draft batch records, change controls, and related documentation. The role requires experience with pilot plant manufacturing, electronic batch records, and MES systems, plus knowledge of drug product processing.