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.