1+ months

Production Specialist - DSP

Charlottetown, PE C1A
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Production Specialist - DSP
Prince Edward Island
North America
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.
  • Comply with safety requirements, 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
  • Perform biologics recovery and purifications using process scale TFF unit, columns and chromatography system
  • Operate and maintain production instruments and equipment, such as pH Meters, Conductivity meters, spectrophotometer, TFF equipment, Peristaltic pumps , rotary pumps , chromatography systems/
  • Perform column packing using packing skids, process analysis using spectrophotometer, integrity testing on various types of filters
  • Write and review batch records, SOPs, qualification documents for the downstream operations
  • Use SAP system for material consumption in production
  • Collaborate with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects
  • Work closely on technology transfer project from Process Development to Manufacturing
  • Work with the upstream manufacturing group to provide resources
  • Perform tasks under minimal supervision, and within tight time lines to meet production schedules
  • Troubleshoot TFF and chromatography operations
  • Assist in the maintenance of production equipment in good condition as per manufacturers specifications
  • Maintain cleanliness of the production areas and assist in disinfection procedures, clean and sterilize items used in purifications
  • Effectively investigate the events that happen during any batch failures using root cause analysis tools
  • Provide leadership to peers on the floor by demonstrating knowledge, expertise and implementing process improvements
  • Bachelors or Masters Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, biochemical engineering, Biology)
  • 3-5 years of experience in the GMP bio manufacturing industry
  • 3-5 years of experience in purification of biologics using large scale TFF filtration and chromatography processes
  • Experience performing investigations and writing deviations
  • Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point), SAP and experience in Unicorn software is required
  • Excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
  • Thorough technical understanding of quality systems and regulatory requirements
  • 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 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.
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  • Science
Posted: 2019-07-10 Expires: 2019-10-07

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Production Specialist - DSP

Charlottetown, PE C1A
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