Brunel
Responsibilities
- Comply with safety requirements (PPE requirements-Respirator Wearing), cGMP, SOP, and manufacturing documentation
- Produce veterinary biologics according to their approved Outline of Product/Product Dossiers and to cGMP guidelines to meet market demand for the Aqua products
- Operate and maintain fermentation production instruments/equipment (scales, stir plates, autoclaves, isolators, conductivity/pH meters, and fume hoods) and operate within product specifications; cleaning, disinfecting and sterilizing equipment
- Weigh materials, rehydrate media, and complete solution preparation, disinfect/clean the isolator and complete isolator processes, assemble bottles, assemble liquids in bottles/feed filter assemblies, and tubing’s. Complete preparation of seed stocks
- Update/Review batch records, SOPs, qualification documents for fermentation operations
- Use SAP system for material consumption/Veeva/Equipment work orders and other local computerized systems used in production
- Responsible for raw inventory management
- Participate in the technology transfer and implementation of new processes to manufacturing
- Perform tasks under minimal supervision, and within tight timelines to meet production schedules
- Assist in the maintenance of production equipment as per manufacturer’s specifications and calibrate, validate, qualify, and perform preventative maintenance as per the validation schedule
- Maintain cleanliness of the production areas and assist in routine disinfection procedures, clean, and sterilize items used during the production activities, perform monthly EM’s and water/steam sampling
- Effectively investigate the events/observations that occur during production and troubleshoot issues arising in fermentation operations/processes
- Complete other duties as required
To apply for this job please visit www.brunel.net.
