PE Global is currently recruiting for a Process Microbiologist on behalf of our client based in Cork, Ireland. The successful candidate will be working on a full-time 12-month contract. As part of the operations team, you will report into the Senior Plant Microbiologist and be responsible for contributing to the microbiological control and assurance program within the department.
Your key responsibilities and impact will include:
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* Leading by example and striving to perform to high standards at all times in compliance with corporate, cGMP, EHS, and other regulatory requirements.
* Performing all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
* Actively leading/supporting process microbiological investigations.
* Performing routine area walkdowns/GEMBAs.
* Supporting and driving strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
* Performing risk assessments for operations projects and business innovation initiatives.
* Defining specific aseptic techniques to be performed for crucial process steps.
* Supporting periodic review of environmental monitoring and in-process sampling trends and identifying appropriate corrective and preventative actions as required.
* Providing effective and timely communication of any adverse trends or activities as appropriate.
The ideal candidate will possess:
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* A Bachelor's degree in a scientific/technical discipline (ideally microbiology).
* A minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
* Knowledge and experience of the shop floor manufacturing process.
* Knowledge of data analytics.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Additional desirable skills and qualifications include validation experience within a Life Sciences or Biopharmaceutical manufacturing environment, Business Excellence and Problem Solving skills, and advanced degrees such as Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
Please note that candidates must have the correct visa to live and work in Ireland. Although PE Global cannot assist with visa sponsorship, we welcome applications from qualified candidates who meet the essential requirements.