Production Specialist

at  Merck Canada inc

Job Description

Comply with safety requirements, cGMP (Good Manufacturing Practices), SOP, and manufacturing documentation.
Produce veterinary biologics according to their approved Outline of Product/Product Dossiers and to cGMP (Good Manufacturing Practices) guidelines to meet market demand for the aqua products.
Perform biologics recovery and purifications using process scale tangential flow filtration unit, columns, and chromatography system.
Operate and maintain production instruments and equipment, such as pH Meters, conductivity meters, spectrophotometer, tangential flow filtration 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, Standard Operating Procedures (SOP), 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 timelines to meet production schedules.
Troubleshoot tangential flow filtration 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.
Other duties as required.
Minimum Qualifications (education, experience and/or training, required certifications):
Grade 12 education, a 2-year college diploma is preferred.
3 years of experience in the Good Manufacturing Practices bio manufacturing industry.
3 years of experience in purification of biologics using large scale tangential flow filtration and chromatography processes.
Experience performing investigations and writing deviations.
Intermediate/expert computer skills using MS Office (Word, Excel, Power Point), SAP experience is required.
Excellent interpersonal skills, both communications and written
Thorough technical understanding of quality systems and regulatory requirements.