Biologics Technician required for a global Biopharma company who are looking to grow their multi-million-euro site based in Westport, County Mayo, Ireland. The Biologics Technician will join their NPI Pharm Tech Operations team who are responsible for all manufacturing activities. This individual will be supporting a tech transfer of an NPI to accommodate clinical manufacture or small and large molecule products. As well as ensuring drug product manufacturing is compliant with site and GMP procedures.
The Biologics Technician will work on a shift pattern which currently involves 8-hour days from Monday to Friday. The shifts will swap bi-weekly and include the following hours:
Day shift: 08:00am – 16:30pm
Evening shift: 16:00pm – 12:00am
Night shift: 12:00am – 08:00am
This will be moving to 24/7 manufacturing later in the year and is subject to change.
On offer is a competitive salary which includes a bonus, shift allowance and overtime.
Key responsibilities of the Biologics Technician:
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.
Qualification / Experience required:
Degree in a scientific subject 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.