Senior Specialist, Engineering — Sterile Fill/Expansion

MSD; Rahway (NJ); Presencial; USD 117.000 - 184.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision

401(k) plan

Paid holidays and vacation

Descripción de la vacante

MSD in Rahway, NJ is expanding its FLEx Sterile clinical supply facility and seeking a Senior Specialist, Technical Operations – Engineering. The role centers on commissioning and qualifying the Optima multi-use filler line, with in-person training in Germany to upskill on automation, aseptic processing, and system-wide troubleshooting.

You will collaborate with formulators, engineers, safety and quality teams, and vendors to ensure compliant, high‑quality clinical supplies across products

Formación

• Bachelor’s or Master’s degree in a relevant engineering/science field with experience in GMP environments.
• Experience with aseptic processing and sterile product manufacturing.
• Strong documentation and SOP writing skills; ability to generate and revise batch records.

Responsabilidades

• Collaborate with stakeholders on equipment and facility design, maintenance, troubleshooting, and process optimization.
• Operate and troubleshoot aseptic filling/lyophilization processes and related equipment.
• Complete Optima training in Germany (10–12 weeks) and transfer knowledge to operations.
• Provide training to operators and engineers on advanced troubleshooting and support.
• Support commissioning, qualification, and validation activities for the Flex Sterile expansion.
• Maintain records, logs, and batch documentation for compliance and traceability.

Conocimientos

Mechatronics

Aseptic Processing

GMP

Documentation

CIM

Educación

B.S. or higher in Mechatronics, Engineering, Automated Sciences, Computer Science, Biology, Chemistry

Master’s degree with 3+ years relevant experience

Herramientas

Optima filling line

Descripción del empleo

MSD in Rahway, NJ is expanding its FLEx Sterile clinical supply facility and seeking a Senior Specialist, Technical Operations – Engineering. The role centers on commissioning and qualifying the Optima multi-use filler line, with in-person training in Germany to upskill on automation, aseptic processing, and system-wide troubleshooting.

You will collaborate with formulators, engineers, safety and quality teams, and vendors to ensure compliant, high‑quality clinical supplies across products