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