Production Specialist

4 months ago

Charlottetown, Canada Merck Canada Inc. Full time

Job Description
**Functions, Duties, Tasks**:
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 mínimal 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.
**Other Information**:
Must be able to work shift work (12-hour daytime shifts, 3-4 days/week including some weekends).
Must have the flexibility/ability to work overtime if the business requires it.
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.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
**Secondary Language(s) Job Description**:
**Fonctions, devoirs, tâches**:
Se conformer aux exigences de sécurité, aux BPF, aux SOP et à la documentation de fabrication.
Produire des produits biologiques vétérinaires conformément à leur plan de produit/dossiers de produit approuvés et aux directives BPF pour répondre à la demande du marché pour les produits aquatiques.
Effectuer la récupération et la purification des produits biologiques en utilisant une unité TFF à l'échelle du processus, des colonnes et un système de chromatographie.
Utiliser et entretenir les instruments et équipements de production, tels que les pH-mètres, les conductimètres, le spectrophotomètre, l'équipement TFF, les pompes péristaltiques, les pompes rotatives, les systèmes de chromatographie.
Effectuer le conditionnement des colonnes à l'aide de patins de conditionnement, l'analyse du processus à l'aide d'un spectrophotomètre, les tests d'intégrité sur divers types de filtres.
Rédiger et réviser les dossiers de lots, les SOP, les documents de qualification pour les opérations en aval.
Utiliser le système SAP pour la consommation de matériaux en production.
Collaborer avec d'autres services impliqués dans la fabrication GMP pour planifier la production, les tests et la co

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