Technical Process Microbiologist

Kenny-Whelan (a specialist division of the CPL group) are hiring a Technical Process Microbiologist   to work on contract at Janssen Sciences in Ringaskiddy Cork 

NEW vacancy DEC 2024

Contact Jenn Dinan on 0214665408 or email jdinan@kenny-whelan.ie 

Process Microbiologist

Location: Cork Barnahely

Contract: Full Time 12 Month Contract

Job Summary

Reporting into the Plant Microbiologist the Technical Process Microbiologist is responsible for active participation in the microbiological control and assurance program within the operations department. Managing activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.

The responsibilities & the impact YOU will have:

• Lead by example and striving 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

ESSENTIAL:

• BSc in a scientific / technical discipline required

• Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment

• Biomanufacturing possess knowledge and experience of shop floor manufacturing process is highly desirable

• Working knowledge of data analytics

• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

DESIRABLE:

• 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.

• Advanced degree (MS, MBA, PhD) preferred

Contact Jenn Dinan on 0214665408 and email jdinan@kenny-whelan.ie