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Computer System Validation (CSV) Engineer

Company: Kelly Technology
Location: San Pablo
Posted on: August 3, 2020

Job Description:

Kelly IT has an opening for a COMPUTER SYSTEM VALIDATION (CSV) ENGINEER to work with our client in Richmond, CA ESSENTIAL DUTIES AND RESPONSIBILITIES: Perform commissioning and qualification of computerized systems. Use your troubleshooting and risk assessment knowledge to work on specialized equipment Create and execute validation documents to ensure appropriate technical content and accuracy based upon specifications and approved procedures RESPONSIBILITIES: Adhere to all company policies and procedures including safety Independently perform and document work following Good Engineering Practices (GEPs) and GDPs --- Manage your own validation projects and effectively report results and progress Develop validation protocols, and operation and maintenance procedures. Perform validation work with minimal supervision Complete all documentation accurately and efficiently Perform inspections to verify cGMP system status is accurate and up-to-date Manage validation discrepancies and system changes Perform FMEA to identify root causes of problems and present possible solutions Contribute to solving complex manufacturing engineering problems --- Be self-motivated and maintain a quality mindset REQUIRED EDUCATION AND EXPERIENCE B.S.in computer engineering or related field Have working knowledge of 21 CFR Part 11, Data Integrity and GAMP 5 Minimum of two years CSV experience Previous experience with one or more of the following: BAS, LIMS, SCADA, PLC, ERP, LMS, DCS Able to troubleshoot and repair simple malfunctions Strong understanding of Good Documentation Practices (GDPs) Must have strong written and verbal communication skills PREFERRED SKILLS: Previous experience in IT Industry Previous experience in the biotechnology industry If you are interested, please email your resume to norh098@kellyit.com Why Kelly--? By partnering with Kelly-- Technology, you'll have direct connections to top companies around the globe-giving you the chance to put your tech skills to work on some of today's most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, keep learning, and move your career forward. About Kelly-- At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.SDL2017

Keywords: Kelly Technology, San Francisco , Computer System Validation (CSV) Engineer, IT / Software / Systems , San Pablo, California

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