Aseptic Lead, Operations - Dundalk

Merck & Co., Inc.

Dundalk, Ireland
Hybrid
5 years sterile manufacturing experience
Media simulation execution and coaching
Grade a isolator knowledge
Merck & Co., Inc. is seeking an experienced Aseptic Lead for their operations in Dundalk, Ireland. The role focuses on enhancing sterile manufacturing standards and compliance, requiring a strong background in aseptic processes and teamwork

Job Summary

  • The role involves leading environmental and media simulation programs while developing aseptic qualification processes within the department.
  • Candidates must manage end-to-end media fill programs 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 audits.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an experienced Aseptic Lead for their operations in Dundalk, Ireland. The role focuses on enhancing sterile manufacturing standards and compliance, requiring a strong background in aseptic processes and teamwork.

Skills & Requirements

Must-have

  • 5 years sterile manufacturing experience
  • Media simulation execution and coaching
  • Grade A Isolator knowledge
  • GMP audit defense experience
  • Environmental and media simulation programs

Nice-to-have

  • Excellent communication and presentation skills
  • Strong planning and organization abilities
  • Ability to align team objectives with site goals
  • Experience in vaccine facility operations

Key Requirements

  • Bachelor's Degree in Science or Engineering
  • Minimum 5 years in drug product sterile manufacturing
  • Prior experience with GMP Audits

Work Rights

Not specified

Tailored Resume

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