*** Aseptic experience is an essential requirement for this role candidates should only apply if they have previous Bio experience *** Your Purpose As a member of the Aseptic Operations function, and as an Aseptic Manufacturing SME, ensures that Equipment for Aseptic Manufacturing (Equipment/ Cleanroom/ Utility) is designed according to company standards and Network Best Practice and is operating as designed. Partners with Site colleagues and other members of the Site Aseptics team, to create an environment of the highest performance standards of Aseptic Manufacturing. Drives continuous improvement in Aseptic Manufacturing Equipment on site. Your Responsibilities (in addition to other duties as assigned) Acts as the Subject matter Expert for Equipment, Cleanroom and Utility systems related to Aseptic Manufacturing Responsible for ensuring that Equipment, Cleanroom and Utility systems required for Aseptic Manufacturing are in compliance with relevant Safety and Environmental Regulations, Aseptic and GMP Regulatory requirements and Network Aseptic Best Practice. Supports existing process Engineering systems related to Aseptic Manufacturing are operating as designed through: Real-Time monitoring of Cleanroom performance (e.g., temperature, Relative Humidity, Differential Pressure, Air Fow velocity etc.) Real-Time monitoring of Utility performance Real-time monitoring of Critical Equipment cycles (e.g., CIP, SIP, VHP, Aseptic Filling, Autoclaves, Lyophilization, Depyrogenation, Bulk Heat Sterilization etc.) Monitoring, investigation and addressing of Automation alarms Trending performance and developing/ executing action plans as required Partners with other members of the Site Aseptics Team (e.g., Quality SMEs, Operations SMEs, Aseptic MQA and Aseptic mentors) to ensure required support is provided to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner, assuring sterility of the product. Participates in troubleshooting & Investigation for equipment/ cleanroom/ Utility related events. Actively participates and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA. As part of the Site Aseptics Team, drives continuous improvement of Aseptic Manufacturing Engineering systems and procedures through: a) Continuously assessing, interpreting, and applying new Aseptic Manufacturing Regulations to Site Engineering systems in a timely manner. b) Development and implementation of Best Practices in Aseptic Manufacturing. Ensures Equipment, Cleanroom, Utility Design related to Aseptic Manufacturing is in compliance with company standards and Network Best Practice though: Provides key input into of the design of systems Ensuring an extensive knowledge of the systems Ensuring an extensive knowledge of company Engineering standards Ensuring that any deviation from our Engineering standards goes through the required approval process. Leading Projects related to equipment, cleanroom and utility equipment change.o Ensuring all alarms are ranked according to criticality. Approves Preventative Maintenance strategy for Equipment, Cleanroom and Utilities. Ensures that all Engineering system changes follow Site Change Control procedures. Ensures appropriate use of Risk Management tools to drive Aseptic performance/ Sterility Assurance Supports regulatory audits as Aseptic/ Sterility Assurance Engineering system subject matter expert. anticipates and provides leadership to the Site Aseptics team, highlighting and leading the introduction of continuous improvement initiatives. Drives a high-performance culture in Aseptic Manufacturing. Drives a culture of Speak-Up. Participates in routine leadership GEMBAs of Manufacturing and Testing areas. Provides key input into Site Contamination Control Strategy, APS Strategy, Aseptic Manufacturing processes. Qualifications & Experience to be successful in your new role; Third Level Degree in an Engineering or equivalent discipline. 3+ Years of experience in a GMP Environment with 1+ years of experience in support of Aseptic Manufacturing Strong knowledge of Regulatory Requirements Project Management experience Excellent communication skills Please click the link below to apply 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: Aseptic Processes Sterile Processes Cleanrooms Biologics Utilities Sterile Equipment
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