Biologics Technician

Our Client a leader in the Pharmaceutical Industry is seeking a Biologics Technician to join their team in their Westport Facility on a Permanent contract.

Key activities you will perform in the role:

·   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. 

The educational background and preferred experience we look for:

·       3rd level qualification in relevant discipline and/or 6 months minimum experience in the pharmaceutical or medical device industry

·       Prior knowledge of aseptic practices in clean room environments is essential.

·       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.

For a confidential discussion and more information on the role, please contact Emma Daly

emma.daly@collinsmcnicholas.ie

0861041202