Computer System Validation (CSV) Engineer
Hybrid in San Francisco, CA, US • Posted 2 hours ago • Updated 2 hours agoContract W2
Remote
Depends on Experience
Akshaya Inc
Fitment
Dice Job Match Score™
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Job Details
Skills
- CSV
- CSV-QA
- 1 CFR part 11
- Part 820
- Annex 11 GxP
- IQ/OQ/PQ
Summary
Position: CSV-QA / SQA Engineer
Location: Preferred Bay area candidate Hybrid
But open for REMOTE ONLY for 100% skill matching candidates
Position Summary:
- Sr CSV-QA / SQA Engineer will work with the Natera Software Engineering team to ensure appropriate
- software validation & lifecycle documentation is in place to support changes to Laboratory and Product
- software systems. This role will provide value-added guidance throughout the software development lifecycle process.
Primary Responsibilities:
- Provide risk-based software validation guidance throughout the CSV process for custom and COTS software following GAMP 5, FDA 21 CFR part 11, Part 820, Annex 11 and GxP requirements.
- Represent software QA on development projects. Perform risk assessments at system and functional levels for computerized systems.
- CSV documentation review/approvals including Validation Plan, URS, FS, Design Specifications,
- System & Functional Risk Assessment, IQ/OQ/PQ Protocol & Report, Trace Matrix, and Validation Summary Report.
- Review & approvals of changes and maintenance release Reports, tickets, change/release-based requirements/specs, TM, test cases/results,
- Experience with Computer Software Assurance (CSA).
- Review & update procedures, requirements & specifications to ensure coverage of functional, configuration, design, part 11 (audit trails, eSig, access controls, etc.) and security requirements.
- Provide guidance and support test execution based on risk and to ensure requirements, including intended use and part 11, are tested.
- Ensure validation state of software systems is maintained.
- Act as subject matter expert for CSV compliance and regulatory requirements related to CSV
- while working with cross functional stakeholders.
- Experience and/or good knowledge of AI systems validation.
Qualifications:
- BS Degree in Computer Science or similar discipline; or equivalent work experience
- 12+ years of experience as a dedicated CSV analyst/lead in validation of cloud-based COTS
- configured and customized software applications.
- Experience working in a CLIA Laboratory environment and/or FDA regulated environment
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 10507810
- Position Id: 8890215
- Posted 2 hours ago
Company Info
Akshaya Inc is one of the premier IT Consulting Services Company in the Bay Area.
Experienced and trained IT professionals at Akshaya Inc provide variety of IT services including IT staff augmentation, application development, IT support and offshore development.
Our world class professionals can assist you with development and support in ERP (SAP, Oracle Applications), Business Intelligence and Data Warehousing, Web development and much more.
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