On-Site Sterile Process Engineer - GMP Clinical Manufacturing

MSD Malaysia; Rahway (NJ); On-site; USD 30,000 - 36,000; Full time

Job summary

Merck seeks a Specialist-level Sterile Process Engineer to drive sterile clinical drug product operations at the Rahway FLEx GMP facility. The role emphasizes leadership, process transfer, scale-up, investigations, and SOP/GXP documentation across cross-functional teams.

The candidate will collaborate with formulation scientists, operations staff, and quality representatives to ensure quality and speed of the pipeline while maintaining regulatory compliance.

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with at least 3 years’ experience.
• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field expected by June 2027.

Responsibilities

• Lead sterile process engineering efforts for GMP clinical manufacturing at the Rahway site.
• Drive process tech transfer, scale-up activities, and quality investigations.
• Manage change control and author SOPs and current GXP documents.
• Collaborate with formulation scientists, operations, and QA to ensure quality and compliance.

Skills

Enterprise leadership

Interpersonal communication

Quality investigations

Change management

GMP/Safety compliance

Process transfer

SOPs & GXP documents

Quality systems

Organization

Independent problem solving

Education

Bachelor’s degree in Chemical Eng/ Chemistry/ Pharmaceutical Sciences or related field with 3+ years experience

Master’s degree in Chemical Eng/ Chemistry/ Pharmaceutical Sciences or related field (completion by Jun 2027)

Job description

Merck seeks a Specialist-level Sterile Process Engineer to drive sterile clinical drug product operations at the Rahway FLEx GMP facility. The role emphasizes leadership, process transfer, scale-up, investigations, and SOP/GXP documentation across cross-functional teams.

The candidate will collaborate with formulation scientists, operations staff, and quality representatives to ensure quality and speed of the pipeline while maintaining regulatory compliance.