Technical Process Microbiologist
Kenny-Whelan, a specialist division of the CPL group, is hiring a Technical Process Microbiologist to work on a full-time 12-month contract at Janssen Sciences in Ringaskiddy, Cork.
Location: Cork, Barnahely
Contract: Full-Time, 12-Month Contract
Job Summary
The Technical Process Microbiologist reports into the Plant Microbiologist and is responsible for participating actively in the microbiological control and assurance program within the operations department. The role involves managing activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
Key Responsibilities
* Lead by example and strive to perform to high standards at all times, adhering to 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 and support process improvements related to contamination risk reduction and microbiological practice enhancement.
* Foster a contamination awareness culture through open and inclusive communication.
* Perform and support Risk Assessments for operations projects and business innovation initiatives.
* Regularly review key performance indicators of the contamination control program and provide effective and timely communication of emerging trends.
* Design and deliver training to support the site contamination control program.
* Support and consult from a micro control perspective on capital project initiatives.
* Maintain customer focus to deliver business requirements.
* Collaborate with Operations Process Microbiologists (internal and platform level), wider Operations team, and cross-functionally to achieve business goals.
* Participate in planning future requirements in Operations.
* Participate in relevant internal and external manufacturing-related audits.
* Understand and support current regulatory trends and future testing requirements.
* Deputize for Plant Microbiologist as required.
Requirements
* BSc in a scientific/technical discipline is required.
* A minimum of 5 years' experience within a pharmaceutical or GMP regulated Operations environment is necessary.
* Biomanufacturing knowledge and experience of shop floor manufacturing process are highly desirable.
* Working knowledge of data analytics is required.
* Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals is necessary.
Desirable Qualifications
* Experience as a manufacturing process specialist/process microbiologist within a Life Sciences or Biopharmaceutical manufacturing environment is desired.
* Business Excellence and Problem Solving skills qualifications (e.g., Six Sigma, Lean Green/Black Belt, or Kepner-Tregoe analysis) are preferred.
* An advanced degree (MS, MBA, PhD) is highly desirable.
Estimated Salary: €60,000 - €80,000 per annum