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Scientific. Clinical. Software Engineering

Validation Specialist

San Mateo Metro Area, CA

Job Type: Engineering Job Number: JN -062019-25139 Region: San Mateo Metro Area

Job Description

Qualifications and Skills
Bachelor s degree in Science or Engineering discipline
3+ years of work experience, preferably in a regulated industry, e.g. medical device, pharmaceutical under GxP environments with knowledge of FDA QSR, ISO 13485, and/or EU MDD/MDR.
Knowledge and experience with 21 CFR Part 11, GAMP5, and/or IEC 62304
Hands-on experience administering and/or managing computerized systems validations, particular change controls, automated testing, and documentation such as requirements documents, testing protocols and reports, etc.
Excellent attention to detail.
Ability to work independently with minimal supervision.

Preferred Qualifications and Skills
Comfortable with Google Apps for Work applications.
Experience using SQL and data analytics platforms.
Proven ability to handle ambiguity and work collaboratively with internal and external cross-functional teams.
Working knowledge of database management, software test tools, project management methodology, change control, quality and system performance methods, and metrics.

Authoring, review, and approval of computer system validation deliverables
Generate test procedures to validate new or previously unvalidated processes
Create technical support tools and triage feature request and technical support queues for Verily s electronic quality systems and tools.
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