Team Horizon is seeking a Engineering Aseptic Specialist for our client based in Sligo. As an Aseptic Operations Specialist, you will act as a site subject matter expert for aseptic manufacturing and sterility assurance. You will provide technical and operational support across aseptic processes, partner closely with cross-functional teams, and help ensure that manufacturing activities are carried out in line with regulatory requirements, site procedures, and standards. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Act as a site subject matter expert for aseptic manufacturing. Provide key input into manufacturing process setup and batch record design. Ensure operations procedures for aseptic manufacturing are compliant with relevant safety, environmental, GMP, and regulatory requirements, as well as network aseptic best practice. Apply risk management tools to drive aseptic performance and sterility assurance, including pFMEA and What If/HAZOP assessments. Partner with Quality, Engineering, Aseptic MQA, Aseptic Mentors, and other site SMEs to support manufacturing shifts and ensure safe, timely, and quality completion of product batches. Observe aseptic technique and behaviors on the floor and provide coaching and feedback where appropriate, particularly during critical activities such as cleaning, sanitization, aseptic setup, EM plate handling, and interventions. Lead and support investigations into sterility, media fill, environmental monitoring excursions, and EMPQ issues, and help establish root cause and CAPA. Own the analysis and trending of environmental monitoring data, including facility and personnel monitoring, and develop action plans in response to trends. Contribute to the ongoing development and implementation of best practices in aseptic manufacturing. Support the site contamination control strategy, aseptic processing strategy, and long-range planning related to aseptic manufacturing. Provide input into cleanroom, equipment, and utility design, qualification and re-qualification, preventive maintenance strategies, and real-time monitoring. Support regulatory audits and inspections as an aseptic and sterility assurance subject matter expert. Support training of operations personnel in aseptic technique and aseptic processing procedures Participate in routine leadership GEMBAs in manufacturing and testing areas. Perform other duties as assigned. What you need to apply: Level 8 NFQ degree in Science, Quality, or Engineering. Minimum 5 years experience in a GMP environment. Minimum 3 years experience supporting aseptic manufacturing. Strong knowledge of regulatory requirements. Strong communication skills, both written and verbal Project management experience. Experience supporting regulatory inspections, including HPRA and FDA. Experience in microbiology. Experience working in a sterile, aseptic, or pharmaceutical environment. Knowledge, Skills and Attributes Strong knowledge of aseptic and sterile processes. Working knowledge of current EU, FDA, ICH, HPRA, and Annex 1 requirements. High attention to detail and strong concentration. Proven problem-solving skills and ability to adapt to changing requirements. Innovative mindset with the ability to propose and implement new solutions. Results-driven with a commitment to meeting targets and metrics. Strong prioritization and time management skills. Excellent interpersonal and collaboration skills. A strong commitment to quality, integrity, and right-first-time performance. Ability to work independently in a largely self-managed environment while engaging effectively with the wider team. Skills: Aseptic Quality Assurance GMP
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