Production Technician – Fermentation

Job Description:

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.

Duties/Responsibilities:

• 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

 Minimum Qualifications:

• Bachelor’s degree or diploma in Biochemistry, Chemistry, Chemical Engineering, or Biology
• Experience with Fermentation

 Candidate Preferences:

• 1-2 years of experience in a GMP 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
• Outlines of Production, cGMP guidelines, and HSE regulations
• Experience performing investigations and writing deviations
• Excellent computer skills using MS Office (Word, Excel, Power Point)
• Thorough technical understanding of quality systems and regulatory requirements

Job Requirements:

• Must be able to work shift work (12 hour daytime shifts, 3-4 days/week including some weekends) and overtime as required
• Must be able to wear clean room garments and remain in clean room area for up to 3 hour time period
• Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
• Must be able to lift, move and maneuver small-medium sized equipment up to 25lbs.
• Requires ability to stand for long periods of time
• Requires frequent ladder or stair climbing
• Must be able to read, write, understand, and comply with appropriate standard operating procedures.