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Lilly Production Specialist - DSP in Charlottetown, Prince Edward Island

Job Category:

Manufacturing

Type of Employment:

Full-Time Employment - FTE

Responsibilities:

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 manufacturer’s 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

Basic Qualificiations:

  • Bachelor’s or Master’s 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.

Additional Skills/Preferences:

Additional Information:

Company Overview:

Posted Date:

Keyword:

Region: North America

City: Charlottetown

State: Prince Edward Island

Country: Canada

Location Details:

Req Id: 50685BR

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