Aseptic Lead, Operations - Dundalk

Merck & Co., Inc.

Dundalk, Ireland
Hybrid
Bachelor's degree in science or engineering
5 years sterile manufacturing experience
Media simulation execution and coaching
Merck & Co., Inc. is seeking an experienced Aseptic Lead in Operations for its Dundalk site to enhance sterile manufacturing standards and drive compliance in cleanroom operations. The ideal candidate will have substantial expertise in aseptic processes and a background in drug product manufacturing

Job Summary

  • The role involves leading Environmental and Media Simulation Programs while developing the Aseptic qualification process within the department.
  • Candidates must manage the End-to-End Media fill program, including strategy, competency building, and GMP Audit defense.
  • The position requires ensuring compliance with global policies and serving as a subject matter expert during deviations or audit activities.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an experienced Aseptic Lead in Operations for its Dundalk site to enhance sterile manufacturing standards and drive compliance in cleanroom operations. The ideal candidate will have substantial expertise in aseptic processes and a background in drug product manufacturing.

Skills & Requirements

Must-have

  • Bachelor's Degree in Science or Engineering
  • 5 years sterile manufacturing experience
  • Media Simulation execution and coaching
  • Grade A Isolator knowledge
  • GMP Audit defense experience

Nice-to-have

  • Excellent communication and presentation skills
  • Strong planning and organization abilities
  • Ability to align team objectives with site goals

Key Requirements

  • Bachelor's Degree required
  • Minimum 5 years Drug Product experience
  • Prior GMP Audit experience

Work Rights

Not specified

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