Aseptic Lead, Operations - Dundalk

med-in.at

Dundalk, Ireland
**
5 years sterile manufacturing experience
Media simulation program management
Grade a isolator knowledge
** Med-in.at is seeking an experienced Aseptic Lead for its operations in Dundalk, Ireland. The role involves ensuring adherence to sterile manufacturing standards, leading programs related to aseptic practices, and contributing to cleanroom operations. **

Job Summary

  • The role involves leading environmental and media simulation programs while developing the aseptic qualification process within the department.
  • Candidates must manage end-to-end media fill programs, including strategy execution and GMP audit defense for sterile manufacturing operations.
  • The position requires ensuring compliance with global policies and serving as a subject matter expert during deviations and audits.

Matching Summary

Match Score: 75

** Med-in.at is seeking an experienced Aseptic Lead for its operations in Dundalk, Ireland. The role involves ensuring adherence to sterile manufacturing standards, leading programs related to aseptic practices, and contributing to cleanroom operations. **

Skills & Requirements

Must-have

  • 5 years sterile manufacturing experience
  • Media simulation program management
  • Grade A Isolator knowledge
  • GMP audit defense capability
  • Cleanroom contamination control procedures

Nice-to-have

  • Excellent communication and presentation skills
  • Strong planning and organization abilities
  • Ability to align team objectives with site goals
  • Experience coaching teams on aseptic practices

Key Requirements

  • Bachelor's Degree in Science or Engineering
  • Minimum 5 years drug product experience
  • Prior GMP audit experience required

Work Rights

Not specified

Tailored Resume

Cover Letter