Overview
Team Horizon is seeking Manufacturing Technicians for our Clients operations team in Mayo. In this role you will be responsible for all manufacturing activities necessary to support a tech transfer of a NPI to accommodate clinical manufacture of small and large molecule products
Why you should apply
Great benefits, a defined career path, and work-life balance!
What you will be doing
* Manufacturing, Process Development, Biologic Drug Product commercial support, and New Product Introduction/Project Management.
* 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.
What you need to apply
* 3rd level qualification in relevant discipline and/or
* 18-24 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
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