Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description We are now hiring a Senior Microbiologist to join the team in Ballytivnan. This person will provide an effective microbiological and analytical service to the sterile biologics facility ensuring that Microbiological procedures and requirements are met. You will join a growing site that is a state-of-the-art Biologics Sterile Fill-Finish liquid and lyophilized product in a vial format. + Implement the facilities sterility assurance program and microbiological support activities (facility design, filling of sterile product and aseptic practices) + Lead and implement microbiological and analytical services to meet and maintain all requirements for aseptic processing, facility design and filling of sterile product + Overview of the EM and utilities program process, aseptic progamme and contamination control strategy in a multiproduct facility. - Provide microbiological/sterility assurance/technical governance of in process and finish product per product requirements + Understand Regulations and business processes required to maintain Abbvie’s and cGMP requirements for sterile product, inclusive of facility design, cross contamination controls, microbiological Laboratory standards and Data Integrity. + Define and update procedures for site relative to microbiological and environmental monitoring. Interface with regulatory and corporate inspectors/auditors + Carry out training as per training plan to support facility sterility assurance program. + Adheres to and supports all EHS & E standards, procedures and policies. EHS Responsibilities: + Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities; + Continually be conscious of your own safety and that of others, always complying with safety notices and barriers; + Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve; + Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve; + Attend all required EHS training and medical surveillance programs; Qualifications + Bachelor Degree qualification in biology or microbiology. + A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines. + 3 -5 years’ (minimum) experience in microbiology is a requirement & working in a sterile/aseptic/pharma environment is a distinct advantage. + Experience in supporting regulatory inspections HPRA, FDA etc is an advantage + Experience in cleaning validation is an advantage Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html