Senior Specialist, Engineering – Sterile Fill Line Expansion

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

Job summary

Merck in Rahway, New Jersey seeks a Senior Specialist, Technical Operations – Engineering for the FLEx Sterile expansion. The role centers on commissioning and qualification of a multi‑use fill line, with hands‑on training in Germany and collaboration with formulators, engineers, and QA to ensure process rigor and regulatory compliance.

The position requires a strong background in aseptic processing, cGMP, and cross‑functional communication, with travel for training and site support.

Qualifications

• Bachelor or Master in a relevant field with years of experience in GMP/biopharma environments.
• Experience with aseptic processing and cGMP for sterile products.
• Strong documentation and SOP writing skills.

Responsibilities

• Collaborate with stakeholders on equipment design, maintenance and troubleshooting.
• Work with aseptic filling and lyophilization equipment across the manufacturing cycle.
• Attend and complete Optima Super user training in Germany (10–12 weeks).
• Provide training on troubleshooting and support functions to operators and engineers.
• Support project assignments and aid in facility and equipment innovation.
• Perform manual and automated operations, maintenance, and documentation.

Skills

Gowning & PPE

Documentation

Communication

SOP writing

Problem solving

Verbal & written comms

GXP compliance

Aseptic processing

Education

Bachelor/Master in STEM

Job description

Merck in Rahway, New Jersey seeks a Senior Specialist, Technical Operations – Engineering for the FLEx Sterile expansion. The role centers on commissioning and qualification of a multi‑use fill line, with hands‑on training in Germany and collaboration with formulators, engineers, and QA to ensure process rigor and regulatory compliance.

The position requires a strong background in aseptic processing, cGMP, and cross‑functional communication, with travel for training and site support.