The Aseptic Lead, Operations position at Merck's Dundalk facility seeks an experienced professional in sterile manufacturing to enhance aseptic practices and ensure compliance with global standards. The role involves leading various aseptic programs, contributing to cleanroom operations, and engaging with teams to build long-term capabilities
Job Summary
The role involves leading environmental and media simulation programs while developing aseptic qualification processes within the department.
Candidates will 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
The Aseptic Lead, Operations position at Merck's Dundalk facility seeks an experienced professional in sterile manufacturing to enhance aseptic practices and ensure compliance with global standards. The role involves leading various aseptic programs, contributing to cleanroom operations, and engaging with teams to build long-term capabilities.
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 capabilities
Ability to align team objectives with site goals
Key Requirements
Bachelor's Degree in Science or Engineering
Minimum 5 years in drug product sterile manufacturing