Sterile GMP Engineering Lead — Expansion & Startup

MSD Malaysia; Rahway, Northern (NJ, KY); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid time off

Job summary

Merck & Co., Rahway, NJ, USA is seeking a Senior Specialist for Sterile Operations to lead the FLEx Sterile Expansion Project. You will guide aseptic formulation, filling, and lyophilization activities and coordinate with QA, IT, and automation teams to ensure startup readiness.

The role requires a Bachelor’s degree in engineering or science with 5+ years in sterile drug product manufacturing; a Master’s degree with 3+ years is preferred. Travel up to 10% may be required.

Qualifications

• Bachelor's degree in Engineering, Science or Operations-related field with at least 5 years of relevant experience.
• Master’s degree with at least 3 years of relevant experience preferred.
• Experience in sterile drug product manufacturing, aseptic technique, GMP and clinical supply operations.

Responsibilities

• Lead operational readiness workstreams for the FLEx Sterile Expansion Project.
• Collaborate with automation, digital and IT teams, equipment vendors and across engineering.
• Develop and maintain SOPs, batch records, training curricula and process documentation.
• Ensure compliant go‑live readiness and support qualification activities (C&Q).
• Support risk assessments, validation activities and continuous improvement initiatives.

Skills

GMP expertise

Sterile operations

Data analysis

Technical leadership

Problem solving

Team collaboration

Education

Bachelor's degree (Engineering/Science)

Master's degree (preferred)

Tools

Robotics

Automated systems

Packaging machinery

MS Access

Excel

Minitab

Power BI

R Shiny

Job description

Merck & Co., Rahway, NJ, USA is seeking a Senior Specialist for Sterile Operations to lead the FLEx Sterile Expansion Project. You will guide aseptic formulation, filling, and lyophilization activities and coordinate with QA, IT, and automation teams to ensure startup readiness.

The role requires a Bachelor’s degree in engineering or science with 5+ years in sterile drug product manufacturing; a Master’s degree with 3+ years is preferred. Travel up to 10% may be required.