- 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
- 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.
- 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 lbs.
- 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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Description
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:
Minimum Qualification (education, experience and/or training, required certifications):
Additional Preferences:
Thorough technical understanding of the quality systems and regulatory requirements.
Other Information: