Biologics Manufacturing Technician
Westport, MO
Job Summary:
We are now recruiting experienced Manufacturing Technicians to join our New Product Introduction team in AbbVie Westport, Co Mayo.
Key Responsibilities:
* 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
* Adhere and support all EHS standard procedures and policies.
Requirements:
* 3rd level qualification in 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
* Well-developed technical writing, organisational, and communication skills are essential
* Experience working in project and team-based environments is essential
* Pro-active approach with proven problem-solving skills is desirable