JO-2407-537961
Our client is a vaccine manufacturing facility based in Ballina in Mayo. Currently recruiting an experienced Microbiologist, reporting directly to the Operations Manager, this is an opportunity to join a positive and dynamic team at an exciting time when the company is poised and ready for growth
For more information and a confidential discussion on this role, please contact Deirdre Murphy on 01 614 6178 or [email protected]
Role
• Support the scale up of production operation on-site in Ballina - delivering on ambitious plans to service the global vaccine, oncology & therapeutic industries by the efficient processing and accurate reading / reporting of Microbiological samples.
• Ensure Regulatory & Quality compliance is applied to SOP writing / updating and the periodic reviews of same.
• Be familiar with relevant regulations provided by the European (EP) & American (USP) Pharmacopeia.
• Ensure all documented procedures are being followed & all logbooks / documentation is completed in real – time and is right first time (RFT).
• Building, leading & developing a strong Microbiology Lab team with assistance / mentoring from Management team.
• Manage and co-ordinate Laboratory team members daily / weekly tasks while evaluating areas of individuals strengths & weakness & to mitigate these.
• Perform EM, water, Microbial limit testing, Bioburden testing and sterility testing using laboratory techniques / cGLP. quality control, and utilizing laboratory skills.
• Be involved in any / all investigations arising from positive results, non-conformances and / or human error deviations.
• Review & interpret all routine & requested Microbiology results.
• Record / tabulate Laboratory results and present at management meetings.
• Quality Control (QC) checks, preparation & revision of SOP's, qualification / validation of test methods.
• Lead continuous improvement projects for the current Laboratory processes
• Conduct routine Preventative maintenance on all Laboratory equipment and scheduling of routine servicing of the Laboratory equipment and to ensure that the Laboratory is stocked with all the materials & consumables that are necessary.
• Supervise / maintain the flock sampling schedule and compile / review results.
• Ensure all gowning & PPE is being worn correctly in relevant areas.
Requirements
• Education: Level 8 Degree in relevant Microbiology discipline ; Masters / PhD in a Micro discipline would be a distinct advantage
• Min 3 years – 5 years in regulated GLP environment
• Previous experience in vaccine manufacturing industry preferred
• Exposure in dealing directly with suppliers & customers would also be an advantage
• Exposure to people management is beneficial but not essential
• Have strong leadership skills, including team building, relationship building and effective stakeholder management.
• Have excellent communication, presentation and interpersonal skills.
• Background / exposure to aseptic techniques & isolators is beneficial
• IT proficiency: MS Office experience is essential
