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Our Client, a leader in the Pharmaceutical Industry, is seeking a Biologics Technician to join their team at their Westport Facility on a Permanent contract.
Key activities you will perform in the role:
1. Manufacturing of pharmaceutical products at different stages of the lifecycle, including clinical, non-clinical, and pre-clinical material.
2. Batch preparation activities (vial washing, load sterilization, area preparation).
3. Work aseptically or as required by the classification of the production area(s).
4. Perform compounding, sterile filtration, and sterile filling activities.
5. Collaborate with vendors on the development and improvement of systems related to single-use technologies.
6. Prepare components and equipment for processing into Grade A environments.
7. Support multi-product manufacturing, switching between different product campaigns smoothly.
8. Comply with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
9. Review and contribute to technical documents, including protocols, reports, and batch manufacturing records.
10. Participate in cross-functional teams with R&D, Engineering, Quality, Supply Chain, Operations, and Validation.
11. Adhere to and support all EHS standards, procedures, and policies.
The educational background and preferred experience we look for:
* 3rd level qualification in a relevant discipline and/or a minimum of 6 months 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, depyrogenation, 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, organizational, and communication skills are essential.
* Experience working in project and team-based environments is essential.
* A proactive approach with proven problem-solving skills is desirable.
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