Computer System Validation (CSV) Engineer
The IBM Watson Health business unit is now looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and life sciences organizations in every way.
We have an exciting opportunity for a Validation Engineer - Design Controls (FDA, MDD, V&V, HIPAA, GxP). As a Validation Engineer specializing in Healthcare regulations and controls you will support the Watson Health solution teams with the Validation of Tools and computer systems used to support the WH QMS as well as development and test of WH Offerings.
Discover what you can make of this moment. Embark on the journey with us at IBM Watson Health.
Responsibilities as a Watson Health Validation Engineer, you will:
- Co-ordinate & manage tool lists required to support Offering V&V
- Manage tools inventory using WH electronic inventory management system
- Lead GxP and Risk Assessments for software tools and complex computer systems
- Lead Validation projects ensuring compliance and deliverable timeline expectations are met.
- Plan and report metrics for assigned validation projects.
- Execution of lifecycle deliverables including; Validation Plans, specification documentation, system configuration, Traceability Matrix in compliance with cGMP and GDP requirements.
- Participate in writing and implementing Test Plans, Test Cases and Test Scripts/Protocols and Traceability Matrix. Executed Test Scripts/Protocols and documented Test Results. Edited and re-tested Test Scripts/ Protocols and signed off (Pass/Fail)
- Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
- Record and close defects found during V&V activities; Investigate failures and retest as needed.
- Provide validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control
- Experience working in regulated environment with exposure in the Regulations & guidance's - GMP, CGMP, GAMP, GXP, 21 CFR Part 11 and CFR Part 820, ISO 14971, Risk Assessment for Medical Device, ISO 1345, IEC 62304.
- CSV experience in Medical device products and / or support systems
- Experience as a CSV Engineer for 3-5 years, with particular experience in validation of software tools & testing medical products
- BSEE/BSCS or equivalent Technical Degree
- Experienced in Software Development Life Cycle (SDLC) Waterfall and Agile methodologies, Manual Testing, White Box and Black Box Testing, Validation and Verification testing
- Strong knowledge of validating products based on SaaS, cloud-based technologies
- Strong Project Management Skills
- Excellent communication skills, written and verbal
- Detail oriented and meticulous worker
- Good organizational skills in recording test results
- Strong belief in quality compliance and following rules
- B.S. in computer engineering or other related engineering discipline
- 3 years required in work experience in a Healthcare device or Life sciences pharmaceutical regulated process mature environment.
- 5 years preferred in work experience in a Healthcare device or Life sciences pharmaceutical regulated process mature environment.
- 3 years required in work experience in a Computer System Validation within a regulated environment, Medical Device / Pharmaceuticals.
- 5 years preferred in work experience in a Computer System Validation within a regulated environment, Medical Device / Pharmaceuticals.
- 1 year preferred work experience in a SW development and Test company preferably in the Cloud and Mobile platform industry segment.
• Cloud, Virtualization, KVM, VMWare
• Integration test frameworks such as Cucumber, Selenium
• Hands-on experience in Automated Test Tools
• Application server middleware (e.g. WebSphere Liberty, Oracle WebLogic)
• Databases (relational and other; DB2, Cloudant, etc.)
• Experienced in testing Software, Web Applications, System Components, and Database
• Exposure in Risk Assessment and Testing Methodologies.
Required Technical and Professional Expertise
Please see the job description
Preferred Tech and Prof Experience
Please see the job description
IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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