Senior Sterile Operations Engineer – Expansion & Startup

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

Paid holidays and vacation

Job summary

Merck’s FLEx Sterile Expansion in Rahway, NJ, is hiring a Sterile Operations Senior Engineer to lead readiness workstreams for a major capacity expansion including a second filling/lyophilization line and new formulation and sterile supply suites.

You will collaborate across automation, IT, and global engineering teams to ensure design, commissioning, qualification, and startup success for a new aseptic drug product filling facility and its operations.

Qualifications

• Experience in sterile drug product manufacturing and GMP/clinical supply operations.
• Ability to operate, set up, adjust, and troubleshoot complex equipment.
• Strong documentation skills and experience with SOPs and validation.
• Proactive problem solving and effective teamwork in a manufacturing setting.
• Experience with data tools: MS Access, Excel, Minitab, Power BI, R Shiny.
• Startup/continuous improvement experience in new GMP facilities.

Responsibilities

• Collaborate with stakeholders on equipment and facility design, maintenance, and troubleshooting.
• Operate aseptic filling, forming, and lyophilization equipment; perform aseptic manipulations.
• Lead project assignments and drive equipment/process innovation.
• Develop SOPs, work instructions, batch records, and training curricula.
• Support compliance, deviations, investigations, and commissioning/qualification activities.
• Drive digital tools for rapid process insights and predictive analytics.

Skills

GMP/quality systems

Problem solving

Data analysis

Cross-functional collaboration

Documentation

Lean/startup mindset

Education

Bachelor's degree in Engineering/Science/Operations Management

Master’s degree (preferred)

Tools

Robotics

Automated systems

Packaging/assembling machinery

Job description

Merck’s FLEx Sterile Expansion in Rahway, NJ, is hiring a Sterile Operations Senior Engineer to lead readiness workstreams for a major capacity expansion including a second filling/lyophilization line and new formulation and sterile supply suites.

You will collaborate across automation, IT, and global engineering teams to ensure design, commissioning, qualification, and startup success for a new aseptic drug product filling facility and its operations.