Sterile Sr. Specialist, Engineering (onsite)

Merck Sharp & Dohme Corp

Rahway, New Jersey, United States
Base: $117,000.00 - $184,200.00; bonus/equity: eli...
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Bachelor's degree in engineering or science
5 years drug product/sterile/validation experience
Gmp compliance and safety requirements knowledge
** This job posting is for a Senior Engineering Specialist at Merck Sharp & Dohme Corp in Rahway, New Jersey, requiring on-site support for sterile operations. The role focuses on maintaining compliance with GMP regulations while managing equipment, projects, and quality engineering in a sterile drug product environment. **

Job Summary

  • This Senior Engineer position provides on-site engineering support for the Rahway, NJ FLEx center focusing on sterile operations within the Pharmaceutical Sciences group.
  • The role requires maintaining facility, utilities, and manufacturing equipment in accordance with GMP and Safety requirements while applying Reliability Maintenance best practices.
  • Candidates will manage the full equipment validation lifecycle, support capital projects, and act as a Subject Matter Expert for sterilization and cleaning validation programs.

Matching Summary

Match Score: 75

** This job posting is for a Senior Engineering Specialist at Merck Sharp & Dohme Corp in Rahway, New Jersey, requiring on-site support for sterile operations. The role focuses on maintaining compliance with GMP regulations while managing equipment, projects, and quality engineering in a sterile drug product environment. **

Salary

Base: $117,000.00 - $184,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering or Science
  • 5 years Drug Product/Sterile/Validation experience
  • GMP compliance and Safety requirements knowledge
  • Sterile drug product manufacturing equipment familiarity
  • CMMS troubleshooting ability (mechanical/electrical)
  • Quality Engineering and deviation investigation skills

Nice-to-have

  • SAP Plant Maintenance experience
  • Capital Project management background
  • eVal/Kneat paperless validation system usage
  • ProCal calibration maintenance system experience
  • Independent problem-solving capabilities
  • Strong technical writing and communication skills

Key Requirements

  • Bachelor's Degree in Engineering or Science
  • Minimum 5 years related Drug Product/Sterile/Validation experience
  • Must be able to work 2nd shift (off-shift)

Work Rights

Not specified

Tailored Resume

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