Sr. Specialist, Engineering (Onsite)

Merck is seeking a Sr. Specialist, Engineering to join the Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, Union County, New Jersey. This on‑site role supports the startup and operational excellence of the FLEx Sterile cGMP clinical supply manufacturing facility.

Key Responsibilities

• Lead engineering activities for the FLEx Sterile facility during its startup phase, ensuring compliance with cGMP regulations.
• Coordinate cross‑functional teams to qualify equipment, utilities, and processes for sterile drug product manufacturing.
• Develop, review, and maintain engineering documentation, including design specifications, validation protocols, and risk assessments.
• Provide technical troubleshooting and root‑cause analysis for equipment and process deviations.
• Support continuous improvement initiatives to enhance facility reliability, throughput, and safety.

Required Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Biomedical Engineering (or related field); advanced degree preferred.
• 5+ years of engineering experience in a cGMP sterile manufacturing environment.
• Strong knowledge of FDA/EMA regulations, USP , and aseptic processing principles.
• Proven project management skills with the ability to lead multidisciplinary teams.
• Excellent written and verbal communication skills.

Compensation

Salary: $107,171.72 per year (fixed). Additional Merck benefits and relocation assistance may be available.

Frequently Asked Questions

What does the Sr. Specialist, Engineering role at Merck involve?

You will lead engineering activities for the FLEx Sterile cGMP facility, ensure regulatory compliance, and support equipment qualification and process improvements.

What qualifications are required for this position?

A Bachelor’s degree in engineering (or related field) with at least 5 years of cGMP sterile manufacturing experience and strong project management skills.

Where is the job location and what is the salary?

The position is onsite in Rahway, Union County, New Jersey, with a fixed annual salary of $107,171.72.