Production Technician - Material Prep Fermentation

Introduction

We are currently hiring a Production Technician - Material Prep Fermentation for our client. The incumbent will be responsible for producing veterinary biologics according to a defined production schedule following cGMP guidelines and specific Outlines of Production to meet market demands for Aquaculture products.

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

Requirements

• A 2-year biotechnology diploma is required; a bachelor’s degree or post-Secondary education in a life science (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred
• 1-3 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 and communication skills
• 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
• Willingness to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator
• Able to lift, move and maneuver small-medium sized equipment – up to 25lbs
• Able to stand for long periods of time, and perform frequent ladder or stair climbing
• Must be able to read, write, understand, and comply with appropriate standard operating procedures (SOPs)

What We Offer

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