Production Technician

1 month ago

Charlottetown, Canada Next Level Group Full time

Position Description: 

To produce veterinary biologics according to a defined production schedule following cGMP guidelines and specific outlines of production to meet market demands. 

Functions, Duties, Task: 

  • Comply with safety requirements (PPE requirements-Respirator Wearing), cGMP, SOP and manufacturing documentation.

  • Produce veterinary biologics according their approved Outline of Product/Product Dossiers and to cGMP guidelines in order to meet market demand for the Aqua products.

  • Operate and maintain fermentation production instruments/equipment and operate within product specifications; cleaning and sterilizing fermenters, inoculations, sampling, media/solution preparation, cultivations, preparation of seed stocks.

  • Write and 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.

  • Participate in the technology transfer and implementation of new processes to Manufacturing.

  • Perform tasks under minimal supervision, and within tight time lines 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 disinfection procedures, clean and sterilize items used in.

  • Effectively investigate the events/observations that occur during production and troubleshoot issues arising in fermentation operations/processes.

  • Complete other duties as necessary 

Minimum Qualification (education, experience and/or training, required certifications): 

  • Post-secondary education in the field of science/biotechnology sciences (preferable BSc or Technical Diploma in Biotechnology)

  • 1-2 years of experience in the GMP bio manufacturing industry (Preferred)

  • Basic -Intermediate computer skills using MS Office (Word, Excel, Power Point) able to learn new computerized system such as SAP, Veeva

  • Excellent interpersonal skills, both communications and written in English. The candidate in this position must be able to communicate effectively with management and staff. 

Additional Preferences: 

Thorough technical understanding of the quality systems and regulatory requirements.

Other Information:

  • Must be able to work shift work (12 hour daytime shifts, 3-4 days/week including some weekends) and overtime as required.

  • 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 25 - 50lbs.

  • Requires ability to stand for long periods of time.

  • Must be able to (Proficient in English) read, write, understand, and comply with appropriate standard operating procedures.

  • Able to work in a confined space if required.

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