Sr. Computer System Validation Consultant from Adept Source
San Carlos, CA
About the Job
Title: Sr. Computer System Validation Consultant
Type of role: Remote Contract
Duration: 12++ Months
Customer Location: San Carlos, CA 94070
This is a 100% Remote role
The Sr. Computer System Validation Specialist will work with the customers' 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.
Job Description:
Type of role: Remote Contract
Duration: 12++ Months
Customer Location: San Carlos, CA 94070
This is a 100% Remote role
The Sr. Computer System Validation Specialist will work with the customers' 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.
Job Description:
- Perform risk-based validation (retrospective and prospective) of computerized system, including custom web portal (SaMD) used from ordering tests to delivering patient reports, following FDA 21 CFR part 11, Part 820, Japan’s PMDA requirements, Annex 11 and GxP requirements.
- Perform risk assessments at system and functional levels for computerized systems.
- Develop software change requests, validation plan, traceability matrix, test protocol & scripts (IQ, OQ & PQ/UAT), Usability Testing and validation report.
- Review & update procedures, requirements & specifications to ensure coverage of functional, configuration, design, part 11 (audit trails, eSig, access controls, etc.) and security requirements.
- Execute test scripts 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.
- 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
- Preferred experience/knowledge with large, complex software validation projects, including custom software application validation, and validation of custom software web portal following FDA and Japan’s PMDA guidelines. Abilities to work with cross functional stakeholders on large & complex system validation.
- Knowledge of regulatory requirements for non-product and product software (21 CFR Part 11, part 820, Japan’s PMDA requirements, Annex 11, 13485, IEC 62304, etc.) to be able to respond to CSV related regulatory/compliance queries.
- Extensive knowledge of QA methodologies, test planning, system dependencies, and software SDLC phases.