Kenny-Whelan, a specialist division of the CPL group, is hiring a Technical Process Microbiologist to work on contract at Janssen Sciences in Ringaskiddy, Cork.
Job Summary
The Technical Process Microbiologist will report into the Plant Microbiologist and be responsible for active participation in the microbiological control and assurance program within the operations department.
Key Responsibilities:
* Lead by example and strive to perform to high standards at all times in compliance with Credo and Standards of leadership.
* Perform all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
* Actively lead/support process microbiological investigations and change controls.
* Perform routine area walkdowns.
* Support and drive process improvements related to the reduction of contamination risks and the improvement of microbiological practices.
Further Requirements:
* BSc in a scientific/technical discipline required.
* Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
* Biomanufacturing knowledge and experience of shop floor manufacturing process highly desirable.
* Working knowledge of data analytics.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Desirable Skills:
* Experience as a manufacturing process specialist/process microbiologist within a Life Sciences or Biopharmaceutical manufacturing environment.
* Business Excellence and Problem Solving skills.
* Qualifications e.g. Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
Benefits:
* Parking
* Staff Discounts