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Computer System Validation Engineer (CSV)

Company: Katalyst Healthcares & Life Sciences
Location: Walkersville
Posted on: August 6, 2022

Job Description:

Job Description Responsibilities: Oversee/Plan/Perform CSV qualification activities with internal, external, local, and global guidelines and regulations Support commissioning activities, projects, and validation functions by performing, preparing and reviewing/approving validation protocols and other documentation for equipment, facilities, and processes. Execute responsibilities as CSV lead for validation related projects; Generate validation final reports. Perform Validation Maintenance and periodic reviews of computerized systems. Monitors the performance of validation projects by tracking appropriate metrics and reporting the results to management. Review and revise CSV SOPs Coach and mentor junior level specialists Participate in audits and inspections conducted by internal and external entities, agencies and clients. Adhere to cGMP and own quality of work and deliverables in a timely manner Handle tasks, deviations, CAPAs, observations, and change controls assigned in Trackwise. Manage to completion in addition to review and oversight. Follow job safety policies and procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Education & Experience: Associate degree in Science or Engineering required; Bachelor's Degree, preferred; equivalent work experience will be considered Significant knowledge of Computer Systems Validation (CSV) and experience from a Pharmaceutical or Chemical Manufacturing or Medical device environment Working knowledge of Microsoft Office required Must be able to walk, sit and stand for several hours; kneel, squat, bend, climb stairs and ladders as needed; Must be able to lift up to 50lbs. Knowledge of ISPE GAMP guidelines Significant knowledge and experience in: 21 CFR Part 11 guidelines Validation IQ, OQ, and PQ protocols Temperature Mapping experience Time Management, Project Management and Schedules Capable of independently discussing validation philosophies during customer audits or regulatory inspections in the presence of a supervisor. Must be willing to work after regular Monday - Friday business hours including weekends when required.

Keywords: Katalyst Healthcares & Life Sciences, Germantown , Computer System Validation Engineer (CSV), IT / Software / Systems , Walkersville, Maryland

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