Process Engineer – Clinical Supply & GMP Pilot Plant

Merck; New Jersey; On-site; USD 72,000 - 113,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Merck in Rahway, New Jersey is seeking an Associate Specialist - Process Engineer to lead clinical supply manufacturing within the FLEx Center’s Oral Solids Dosage team. You will ensure safety and quality of on‑site batch production and drive process rigor in a GMP piloting environment.

This role requires experience with GxP manufacturing, and knowledge of electronic batch records and MES systems, plus the ability to lead quality investigations, changes, and cross‑functional collaboration to

Qualifications

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

Responsibilities

• Lead on-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 and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
• Foster culture of collaboration, learning and innovation.

Skills

GxP manufacturing

Pilot plant experience

Electronic batch records

MES systems

Drug product processing

Problem solving

Education

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

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

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

Job description

Merck in Rahway, New Jersey is seeking an Associate Specialist - Process Engineer to lead clinical supply manufacturing within the FLEx Center’s Oral Solids Dosage team. You will ensure safety and quality of on‑site batch production and drive process rigor in a GMP piloting environment.

This role requires experience with GxP manufacturing, and knowledge of electronic batch records and MES systems, plus the ability to lead quality investigations, changes, and cross‑functional collaboration to