Sr. Specialist, Engineering (Onsite)
Merck
August 19, 2026
On-site
Rahway, NJ
Operations
Role: Sterile Process Engineer (Senior Specialist)
Responsibilities:
- Support pipeline’s most technically complex sterile drug product formulations/process development via process tech transfers, scale-up, quality investigations, change management, and authoring GMP SOPs/protocols.
- Collaborate with development scientists, engineers, operations, and quality to ensure clinical supply quality and process scientific rigor.
- Ensure on-site delivery at New Jersey FLEx GMP facility; report to the Sterile Process Engineering Lead.
Education Minimum Requirements:
- Bachelor’s in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field +5 years relevant experience.
- Master’s in same fields +3 years relevant experience; or
- PhD in same fields (years of relevant experience not fully specified).
Required Experience/Skills:
- Demonstrated enterprise leadership; strong verbal/written communication.
- Experience leading quality investigations and change management.
- Familiarity with US and EU GMP and safety compliance.
- Ability to translate drug product/process needs into executable steps/procedures.
- Ability to prepare SOPs and current GXP documents; experience with quality systems.
- Strong organizational skills; desire to learn, contribute, and lead; independent problem-solving.
Preferred Experience/Skills:
- Sterile GMP facility startup experience.
- Knowledge of investigational drug regulatory requirements.
- Understanding of clinical supply chain operations.
- Expertise in drug product aseptic processing, equipment, and sterile technique.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on the posting).
Responsibilities:
- Support pipeline’s most technically complex sterile drug product formulations/process development via process tech transfers, scale-up, quality investigations, change management, and authoring GMP SOPs/protocols.
- Collaborate with development scientists, engineers, operations, and quality to ensure clinical supply quality and process scientific rigor.
- Ensure on-site delivery at New Jersey FLEx GMP facility; report to the Sterile Process Engineering Lead.
Education Minimum Requirements:
- Bachelor’s in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field +5 years relevant experience.
- Master’s in same fields +3 years relevant experience; or
- PhD in same fields (years of relevant experience not fully specified).
Required Experience/Skills:
- Demonstrated enterprise leadership; strong verbal/written communication.
- Experience leading quality investigations and change management.
- Familiarity with US and EU GMP and safety compliance.
- Ability to translate drug product/process needs into executable steps/procedures.
- Ability to prepare SOPs and current GXP documents; experience with quality systems.
- Strong organizational skills; desire to learn, contribute, and lead; independent problem-solving.
Preferred Experience/Skills:
- Sterile GMP facility startup experience.
- Knowledge of investigational drug regulatory requirements.
- Understanding of clinical supply chain operations.
- Expertise in drug product aseptic processing, equipment, and sterile technique.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on the posting).