Aseptic Lead, Operations - Dundalk

Merck Sharp & Dohme Corp

Dundalk, Ireland
Hybrid
5 years sterile manufacturing experience
Media simulation execution and coaching
Grade a isolator knowledge
Merck Sharp & Dohme Corp is seeking an experienced Aseptic Lead for their Dundalk site, focusing on enhancing sterile manufacturing standards and practices. The ideal candidate will have a strong background in drug product and sterile manufacturing operations, with at least 5 years of experience, and will play a crucial role in compliance and capability building within the team

Job Summary

  • The role involves leading Environmental and Media Simulation Programs while developing aseptic qualification processes within the department.
  • Candidates must manage the End-to-End Media fill program, including strategy, competency building, and GMP Audit defense.
  • This position serves as a trusted subject matter expert shaping how aseptic practices are applied and sustained across the Dundalk site.

Matching Summary

Match Score: 85

Merck Sharp & Dohme Corp is seeking an experienced Aseptic Lead for their Dundalk site, focusing on enhancing sterile manufacturing standards and practices. The ideal candidate will have a strong background in drug product and sterile manufacturing operations, with at least 5 years of experience, and will play a crucial role in compliance and capability building within the team.

Skills & Requirements

Must-have

  • 5 years sterile manufacturing experience
  • Media simulation execution and coaching
  • Grade A Isolator knowledge
  • GMP audit defense experience
  • Environmental monitoring program leadership

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

Cover Letter