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, Facebook, Instagram, YouTube, LinkedIn, and TikTok.
Job Description
We are currently looking for an Aseptic Manufacturing Specialist to join our team in AbbVie Ballytivnan, Sligo. This person will be responsible for defining and updating procedures related to gowning, aseptic behaviors, and contamination control strategy. The role requires expertise in sterility assurance, microbiological monitoring, environmental monitoring, and contamination control, with an opportunity to positively impact our growing site in Sligo.
* Implement effective training and requalification programs for isolator activities, gowning, and aseptic behaviors on site.
* Support and govern sanitization programs.
* Assist with the sterility assurance program and microbiological support activities to ensure compliance from design to end-user processes.
* Represent AbbVie Ballytivnan in aseptic governance to ensure all aseptic processing, facility design, and filling of sterile products meet regulatory and global standards.
* Support EM and utilities programs, aseptic protocols, and contamination control strategies in a multiproduct facility.
* Maintain compliance with regulations and business processes, including cGMP, facility design, cross-contamination controls, and Data Integrity.
* Define and update procedures related to gowning, aseptic behaviors, and contamination control.
* Conduct training sessions as per the training plan to support the sterility assurance program.
* Adhere to and promote all EHS standards, procedures, and policies, including PPE use, incident reporting, and safety practices.
* Support a culture of EHS excellence and continuous improvement.
Qualifications
* Thorough knowledge of aseptic and sterile processes, GMP environment experience, and familiarity with EU/FDA/ICH/HPRA guidelines.
* Minimum of 3-5 years’ microbiology experience, preferably in a sterile/aseptic/pharmaceutical environment.
* Experience supporting regulatory inspections (HPRA, FDA, etc.) is advantageous.
* Bachelor’s degree in biology or microbiology.
Additional Information
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, and serving our community. We welcome applicants from diverse backgrounds and encourage those seeking reasonable accommodations to learn more via the provided links. #J-18808-Ljbffr