Validation Engineer - Katalyst Healthcares & Life Sciences
Chicago, IL 60601
About the Job
Responsibilities:
- Software Quality Assurance with Review and Approval Experience for SDLC Deliverables.
- Experience should have earlier in career in SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP testing).
- Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release).
- Several years of SQA experience with Review and Approval of SDLC deliverables (e.g., MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification).
- Support as SQA in the Review and Approval and implementation of regulated IT applications.
- Collaborate with the development team to build compliance capabilities to assure the quality of the deliverables and ensures business needs are met.
- Strong Validation Resource with 7+ yrs Experience.
- Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
- Previous experience with automated testing and implementation.
- Proficient in understanding of GxP regulations and validation principles.
- Good experience in Review of CAPA's, Change Control and Defects as it applies to Software Validation.
- Familiarity with a range of applications/tools including JIRA, Confluence, Client-ALM, Tosca, Confluence, Veera, Qtest, M-Files, or other continuous integration tools
- Knows the difference between Waterfall and Agile software development methodologies
- Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency.
- Must pass background and reference checks.
Source : Katalyst Healthcares & Life Sciences
