Microbiologist- Aseptic Manufacturing Lead

4 weeks ago

County Dublin, Ireland PE Global Full time

The Role: PE Global are recruiting for a Microbiologist Aseptic Manufacturing Lead to be based in Dun Laoghaire 12 Month initial contract Hybrid Onsite 3 days a week Microbiologist Aseptic Manufacturing Lead An exciting opportunity has arisen for a Microbiologist Aseptic Manufacturing Lead at our clients site in South Dublin We are seeking a highly skilled professional with deep technical and operational expertise in aseptic drug product manufacturing. This role is pivotal in driving excellence in aseptic processing, ensuring compliance with regulatory standards, and representing the Dublin site on a global stage within clients manufacturing network. As the Microbiology Aseptic Manufacturing Lead, you will play a key role in enhancing aseptic processing knowledge, leading strategic initiatives, and collaborating across teams to advance aseptic standards. Key Responsibilities: Serve as the Subject Matter Expert (SME) and primary point of contact for aseptic manufacturing processes, driving site and network projects. Lead and contribute to strategic initiatives focused on aseptic process improvements, including Contamination Control and Aseptic Process Simulations (APS). Collaborate with cross-functional teams to address operational challenges, providing expertise and resolving escalated technical issues. Oversee the implementation of aseptic techniques, ensuring full compliance with regulatory and industry standards. Develop and deliver training programs to enhance aseptic manufacturing techniques and procedures. Monitor and analyze aseptic process performance, identifying opportunities for continuous improvement. Ensure the successful execution of aseptic process validations and qualifications. Required Qualifications & Experience: Bachelors degree in Microbiology or a related scientific discipline. A minimum of 5+ years of experience in the pharmaceutical industry, with a strong focus on aseptic manufacturing. Extensive knowledge of cGMP regulations and compliance requirements, including EudraLex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products. This is a unique opportunity to shape the future of aseptic manufacturing within a global biotechnology leader. If you are passionate about driving innovation, compliance, and operational excellence, we invite you to apply for the role Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey Mccarthy on or alternatively send an up to date CV to 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: aseptic manufacturing microbiology aseptic process

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