Process Microbiologist

Process Microbiologist

Reporting into the Snr Plant Microbiologist the Operations 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.

Responsibilies:

• 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.
• Perform routine area walkdowns / GEMBA's.
• Support and drive 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.
• Perform Risk Assessments for operations projects and business innovation initiatives
• Define specific aseptic techniques to be performed for crucial process steps
• Support periodic review of environmental monitoring and in-process sampling trends and identifies appropriate corrective and preventative actions as required.
• Provide effective and timely communication of any adverse trends or activities as appropriate.
• Achieve individual goals through actively working with departments and individuals
• Maintain customer focus to deliver business requirements.
• Collaborate with Process Microbiologists internally and across the JnJ network
• Access global microbiology support resources, as required.
• Review and approve relevant SOP's and WI's.
• Participate in the planning for future requirements in Operations.
• Ensure microbiological control strategy is consistent with GMP requirements and company requirements.
• Participate in relevant internal and external manufacturing related audits.
• Understand and support current regulatory trends and future testing requirements.
• Deputize for the Microbiology team, as required
• Comply with EHS rules and procedures at all times.

Basic Qualifications:

• BSc in a scientific/technical discipline required. Ideally microbiology discipline
• Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
• Possess knowledge and experience of the shop floor manufacturing process.
• Possess knowledge of data analytics
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Fred Chesne on +353 85 178 6539 or send your CV to [email protected]