Technical Process Microbiologist
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.
The ideal candidate will have a BSc in a scientific/technical discipline and minimum 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
* 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.
The responsibilities include performing routine area walkdowns, supporting and driving process improvements related to the reduction of contamination risks and the improvement of microbiological practices, fostering and promoting a contamination awareness culture through open and inclusive communication, and more.
The ideal candidate will have biomanufacturing knowledge and experience of shop floor manufacturing process, working knowledge of data analytics, and knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
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.
* Foster and promote a contamination awareness culture through open and inclusive communication.
* Perform and support Risk Assessments for operations projects and business innovation initiatives.
* Regular review of key performance indicators of the contamination control program.
* Provide effective and timely communication of any emerging trends, as appropriate.
* 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 at platform level), wider Operations team, and cross-functionally to achieve business goals.
* Participate in the planning for 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.