Job Description
We are currently seeking an experienced Manufacturing Technician to join our team in AbbVie Westport, Co Mayo. As a member of our New Product Introduction team, you will be responsible for all manufacturing activities necessary to support the tech transfer of a NPI to accommodate clinical manufacture of small and large molecule products.
As a key member of our team, you will be responsible for ensuring that drug product manufacturing is performed in compliance with site and GMP procedures, and that scheduling and manufacturing meets global request timelines. Flexibility around shifts is required, as this will be a 12 hour shift based role, with monthly rotational shift pattern, covering days and nights and weekends.
Key activities you will perform in the role include:
* Manufacturing of pharmaceutical products at different stages of lifecycle including clinical, non-clinical and pre-clinical material.
* Batch preparation activities (vial washing, load sterilization, area preparation).
* Work aseptically or as required by the classification of the production area(s).
* Perform compounding, sterile filtration and sterile filling activities.
* Work with various vendors on the development/improvement of new and existing systems regarding single use technologies.
* Prepare components and equipment for processing into Grade A environments.
* Aid in running a multi-product suite, changing between different product campaigns without issue.
* Perform environmental monitoring.
* Comply with Good Manufacturing Practices (GMP) and with Standard Operating Procedures (SOPs).
* Review and contribute to technical documents, including protocols, reports and batch manufacturing documents.
* Participate in cross-functional teams with other functions, including R&D, Engineering, Quality, Supply Chain, Operations and Validation.
Required Skills and Qualifications:
The following skills and qualifications are required for this position:
* 3rd level qualification in a relevant discipline and/or 12-18 months minimum experience in the pharmaceutical or medical device industry.
* Experience working in cleanroom environments essential.
* Prior knowledge of aseptic practices desirable.
* Strong knowledge of GMP regulatory guidelines, quality systems, drug product manufacturing and validation is desirable.
* Understanding of autoclave sterilization, depryogenation, and filter integrity testing is desirable.
* Knowledge of lyophilization and freeze dryer operations is desirable.
* Experience with single use technologies is desirable.
Benefits:
At AbbVie, we offer a range of benefits to our employees, including great benefits, a defined career path, and work-life balance. We take pride in giving something back to our community and prioritize equality, equity, diversity and inclusion. Join us and discover how your individual contributions can make a real impact.
Are you ready to grow with us and achieve your goals? Apply today!