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CSV Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Sunnyvale
Posted on: June 16, 2022

Job Description:

Job Description Responsibilities: Subject matter expert of validation of Computerized Systems and associated business system interfaces. Work within cross-functional project teams representing Validation to ensure projects are completed in line with procedures, regulations and business needs. Measure and report project execution progress. Responsible for decisions that impacts the project implementation, solving complex technical problems without compromising compliance/ Regulatory requirements Performing System based Risk Assessments to ensure validation efforts are directed at the systems that have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management. Development and review validation related documents throughout system lifecycle. Proficiently write/review validation documentation including SOPs/WIs documentation with minimal consultation. Highly skilled in writing and executing test script in electronic test execution system. Support Inspection Readiness activities by developing and maintaining Validation Dossiers. Deliver relevant trainings to project teams before beginning computerized system validation activities. Demonstrate an effective and flexible communication style when communicating with the team and cross functionally. Education & Experience: Bachelor's degree or higher in relevant computer/regulatory/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality orientation. 5 years of relevant experience in a high volume commercial / clinical pharma / healthcare facility, supporting computer applications. Experience with Enterprise and Global Quality Systems, Data Visualization tools, Medical Inquiry (Medical Affairs), Manufacturing System is a plus. Knowledge of GxP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, EudraLex Volume 4 and Annex 11. Excellent interpersonal, collaborative, communication (written and verbal) and time-management skills are essential. Proven track record in current and previous roles. Results, Performance and Accountability driven. Flexibility and adaptability to changing needs and work product requirements.: 22-00437 : Cupertino, CA:

Keywords: Katalyst Healthcares & Life Sciences, Sunnyvale , CSV Engineer, Engineering , Sunnyvale, California

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