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Production Technician - Fermentation (Night Shift)

49130
Production Technician - Fermentation (Night Shift)
Charlottetown
Prince Edward Island
North America
Canada
  • 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
  • Thorough technical understanding of quality systems and regulatory requirements
49130BR
  • 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)

· Must be able to work night shifts (12 hour night 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.

Position purpose - 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.
This position will begin with day shifts for training and then go into a continuous night shift rotation