Process Microbiologist
8 hours ago
PE Global is currently recruiting for a Process Microbiologist on behalf of our client based in Cork. Full Time 12 Month Contract 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. 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. Perform routine area walkdowns / GEMBAs. 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 network Access global microbiology support resources, as required. Review and approve relevant SOPs and WIs. 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. We would love to hear from YOU, if you have the following essential requirements: ESSENTIAL: 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. DESIRABLE: Validation experience 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) Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey on or alternatively send an up-to-date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: microbiology site microbiology process microbiology
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