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Biologics Validation Manager

Company: DiscGenics
Location: Salt Lake City
Posted on: February 22, 2021

Job Description:

This full-time role will focus on qualification/requalification of facilities, utilities, manufacturing and analytical equipment. The successful candidate will lead the equipment validation effort, working closely with external contractors (if applicable), and internal DiscGenics equipment subject matter experts. The facility and utilities include GMP labs and cleanrooms, process gases, and autoclaves. The manufacturing equipment includes cell processing, harvest, aseptic filling, and labeling of DiscGenics cell therapy products. The successful candidate will work with the development, quality, and manufacturing teams to design, test, integrate and implement all processes, equipment, utilities, and documentation following cGMP and QbD principles. True to a startup, this position may require one to utilize other broad and variable skillsets to accomplish our primary objectives.ResponsibilitiesLead validation effort (including facilities, utilities, manufacturing and analytical equipment)Assist with software, automated systems and controls validationPrimary interface with external validation contractors/firmsProvide tracking and organization of equipment validation documentation and activityProvide regular updates to internal team on validation progressURS, DQ, and risk assessment generationFAT, SAT, IQ, OQ and PQ creation and executionTemperature mappingKAYE validator useKnowledge of system validation "life-cycle" conceptIntegrate Quality-by-Design (QbD) principles and participate in risk assessments for the process, personnel and equipmentAssist with development of system boundary diagramsData analysis and clear communication of results, including appropriate cGMP documentation for eventual validation package submission and regulatory inquiriesDemonstrate a high level of initiative in troubleshooting data analysisDevelop and implement protocols and procedures that embody best practices in biologics manufacturing (cGMP, QbD)RequirementsB.S. in life sciences or engineering6-8 years of experience in biologics or pharmaceutical industryEffective time management skillsSelf-motivated with focus on continuous improvementComfort working in the fluid structure of start-up biotechIntegrity, confidence, and passionIdeal candidate has experience in validation of biologics equipment for cGMP manufacturingIdeal candidate has experience in formulation and filling engineering and operationsIdeal candidate has experience in validation of software, computer and automated systemsBenefitsDiscGenics offers a creative, team-oriented scientific environment, along with a strong compensation package that includes salary, stock options, and a comprehensive benefits package.

Keywords: DiscGenics, Salt Lake City , Biologics Validation Manager, Executive , Salt Lake City, Utah

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