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.