Lead Sterile Process Engineer (Onsite, NJ)

Merck; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck is seeking a Sterile Process Engineer (Senior Specialist) for its FLEx Center in Rahway, NJ. The role drives process development, tech transfers, and quality investigations to enable rapid, compliant clinical drug product manufacturing.

The candidate will work closely with development scientists, engineers, operations, and quality teams to ensure product quality, regulatory compliance, and timely delivery of sterile clinical supplies.

Qualifications

• Bachelor’s degree with a minimum of 5 years relevant experience; Master’s with 3 years; PhD with relevant experience.

Responsibilities

• Lead process development and tech transfers for sterile clinical drug product operations.
• Prepare GMP SOPs and current GXP documents.
• Coordinate with development scientists, engineers, operations, and quality representatives to ensure product quality.

Skills

Enterprise leadership

Communication

Quality investigations

GMP familiarity

SOP & GXP documentation

Quality systems

Organizational skills

Problem-solving

Change management

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

PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field

Job description

Merck is seeking a Sterile Process Engineer (Senior Specialist) for its FLEx Center in Rahway, NJ. The role drives process development, tech transfers, and quality investigations to enable rapid, compliant clinical drug product manufacturing.

The candidate will work closely with development scientists, engineers, operations, and quality teams to ensure product quality, regulatory compliance, and timely delivery of sterile clinical supplies.