Job Title:Operations Aseptic SpecialistLocation:Sligo, IrelandContract:12 MonthsRate:Up to €36 per hourOverviewWe are seeking anOperations Aseptic Specialistto join the biologics manufacturing team in Sligo. This role is a key part of strengthening the site'saseptic capabilityand ensuring that all products are manufactured to the highest sterility and regulatory standards. As an Aseptic Manufacturing SME, you will play a critical role inshaping best practices, supporting operationson the manufacturing floor, and driving a strong culture of aseptic excellence.ResponsibilitiesAct as a site Subject Matter Expert (SME) for Aseptic Manufacturing.Provide key input into setting up the manufacturing process .Provide key input for the Manufacturing Batch Record .Ensure Operations procedures comply with Safety and Environmental Regulations, Aseptic and GMP regulatory requirements, and network best practices .Ensure effective use of Risk Management tools to support aseptic performance and sterility assurance, including pFMEA and What If/HAZOP assessments .Partner with Quality SMEs, Engineering SMEs, Aseptic MQA, and Aseptic Mentors to ensure manufacturing shifts have the support needed to complete product batches safely, compliantly, and in an aseptic manner .Drive a high-performance culture through communication, colleague engagement, and a speak-up culture.Routinely observe aseptic technique and behaviour of shift teams, giving feedback during critical activities such as Cleaning, Sanitization, Aseptic Set-up, EM plate handling, and Interventions .Lead and support investigations into sterility, media fill, EM excursions, and EMPQ issues, contributing to root cause and CAPA development.Own analysis and trending of Environmental Monitoring (EM) data, including responsibility for the EM Visualization Tool. Develop and execute action plans to address EM trends.Drive continuous improvement of aseptic procedures by:a) Assessing and applying new Aseptic Manufacturing regulationsb) Developing and implementing best practicesEnsure all procedures and changes follow site Change Control procedures.Provide key input into the Site Contamination Control Strategy .Provide key input into the site APS strategy .Provide key input into Site LRP for Aseptic Manufacturing.Provide key input into cleanroom/equipment/utility design, qualification, re-qualification, and preventative maintenance strategies.Support regulatory audits as an Aseptic/Sterility Assurance SME .Support training of Operations personnel in aseptic technique and aseptic processing procedures .Participate in routine leadership GEMBAs of manufacturing and testing areas.Qualifications & ExperienceThird-level degree in Science, Quality, or Engineering.5+ years in a GMP environment, with 3+ years supporting Aseptic Manufacturing (non-negotiable) .Strong knowledge of EU GMP Annex 1, FDA 21 CFR Part 610, 210, 211, and FDA guidance " Sterile Drug Products Produced by Aseptic Processing - CGMP ."SME-level experience with risk management tools including contamination control strategy, pFMEA, HAZOP, and What If .Experience tracking and trending environmental monitoring data as a microbial SME.Experience in investigations related to sterility, media fill, environmental monitoring excursions, and EMPQ, including root cause and CAPA .Only candidates with avalid work visa for Ireland or an EU passportwill be considered.To discuss this role in more detail, contactCornéat orfor a confidential discussion.