Aseptic Lead, Operations - Dundalk

39med

Dundalk, Ireland
**
5 years sterile manufacturing experience
Media simulation program leadership
Grade a isolator knowledge
** 39med is seeking an experienced Aseptic Lead for their Dundalk facility to oversee and enhance sterile manufacturing practices. The ideal candidate will have a strong background in aseptic operations, particularly with Media Simulations and GMP compliance, and will thrive in a hybrid working environment that promotes flexibility. **

Job Summary

  • The role involves leading environmental and media simulation programs to strengthen sterile manufacturing standards across the site.
  • Candidates will manage the end-to-end media fill program, including strategy execution and GMP audit defense.
  • This position requires a subject matter expert to develop isolator glove management programs and ensure compliance with global cGMP policies.

Matching Summary

Match Score: 75

** 39med is seeking an experienced Aseptic Lead for their Dundalk facility to oversee and enhance sterile manufacturing practices. The ideal candidate will have a strong background in aseptic operations, particularly with Media Simulations and GMP compliance, and will thrive in a hybrid working environment that promotes flexibility. **

Skills & Requirements

Must-have

  • 5 years sterile manufacturing experience
  • Media simulation program leadership
  • Grade A Isolator knowledge
  • GMP audit defense experience
  • End-to-end media fill management

Nice-to-have

  • Excellent communication skills
  • Cleanroom contamination control expertise
  • Training program management ability
  • Strategic alignment with site goals

Key Requirements

  • Bachelor's Degree in Science or Engineering
  • Minimum 5 years in drug product operations
  • Experience with GMP Audits

Work Rights

Not specified

Tailored Resume

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