Clinical Supply Process Engineer - Non-Sterile Solids

MSD

Rahway (NJ)

On-site

USD 72,000 - 113,000

Full time

6 days ago
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Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Specialist – Process Engineer to lead clinical supply manufacturing in the FLEx Center. You will drive on-the-floor batch production, ensuring safety, quality, and regulatory compliance for non-sterile oral solids.

Collaborate with formulators, engineers, and QA to draft GxP documents, support equipment qualification, and investigate deviations. This role emphasizes problem solving, cross-functional teamwork, and continuous improvement in a

Qualifications

  • Experience executing GxP manufacturing in pilot plant environment.
  • Experience with electronic batch records and MES systems.
  • Knowledge of drug product processing.
  • Willingness to learn and contribute through independent problem-solving.
  • Experience with 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 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
Electronic batch records
MES systems
Drug product processing

Education

Associate degree in chemical engineering or related
Bachelor's in chemical engineering, Chemistry or related
Master's in chemical engineering or related

Tools

MES software

Job description

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Specialist – Process Engineer to lead clinical supply manufacturing in the FLEx Center. You will drive on-the-floor batch production, ensuring safety, quality, and regulatory compliance for non-sterile oral solids.

Collaborate with formulators, engineers, and QA to draft GxP documents, support equipment qualification, and investigate deviations. This role emphasizes problem solving, cross-functional teamwork, and continuous improvement in a

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