Sterile Process Engineer — GMP Clinical Manufacturing (NJ)

Merck & Co.; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive health benefits

Job summary

Merck & Co. is seeking a Sterile Process Engineer at the Specialist level for its Rahway, New Jersey facility. The role leads process transfer, scale-up, and quality investigations to enable fast, compliant clinical drug product manufacturing.

The candidate will collaborate with formulation scientists, engineers, and quality representatives to ensure rigorous processes and GMP adherence, reporting to the Sterile Process Engineering Lead within PSDD.

Qualifications

• Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience
• Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2027)

Responsibilities

• Lead process transfer, scale-up and tech transfer activities for sterile clinical drug product operations.
• Author GMP SOPs and QC/QA documentation to support manufacturing.
• Collaborate with formulation scientists, engineers, operations, and quality teams to ensure product quality and regulatory compliance.

Skills

Leadership

Interpersonal communication

Quality investigations

GMP compliance

SOP writing

Quality systems

Organizational skills

Problem solving

Education

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

Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field (expected by June 2027)

Job description

Merck & Co. is seeking a Sterile Process Engineer at the Specialist level for its Rahway, New Jersey facility. The role leads process transfer, scale-up, and quality investigations to enable fast, compliant clinical drug product manufacturing.

The candidate will collaborate with formulation scientists, engineers, and quality representatives to ensure rigorous processes and GMP adherence, reporting to the Sterile Process Engineering Lead within PSDD.