To produce veterinary biologics according to a defined production schedule following cGMP guidelines and specific outlines of production to meet market demands for Aquaculture products.
Comply with safety requirements, cGMP, SOP and manufacturing documentation.
Produce antigens in a timely manner according to their approved Outline of Production/Product Dossiers and to cGMP guidelines
Support Antigen production and freeze dried vaccines production according to Standard Operating Procedures and Protocols.
Environmental monitoring – viable and non-viable monitoring
Prepare materials for production needs
Organizing, labeling, wrapping and sterilization of materials
Ensure equipment and materials are in state of readiness for production technicians
Cleaning/disinfection of production areas and materials as outlined in specific Standard Operating Procedures.
Assist in Buffer peroration and other supporting activities related to down streaming process.
Perform routine activities such as recording temperatures and room pressures, performing purified water sampling and clean steam sampling.
Support fermentation operator – cleaning fermenters and associated parts, set up/tear down of fermenters
Preparation and modification of Standard Operating Procedures as required
Complete other duties as necessary
Bachelor’s Degree or Post-Secondary education in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, Biology)
1-2 years of experience in the GMP bio manufacturing industry
Experience with Fermentation in a cGMP Manufacturing environment
Experience in the preparation of Standard Operating Procedures, preparation of batch records as per specific GMP requirements
Excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management, staff and other departments such as Quality Control and Quality Assurance.
Outlines of Production, cGMP guidelines, and HSE regulations
Experience performing investigations and writing deviations
Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point)
Thorough technical understanding of quality systems and regulatory requirements