Job description

Validation Engineer

Location - Marlborough, MA – Remote – need some one in EST And nearby to MA

Job Description:

• Demonstrate extensive abilities and a proven record of success as a team leader in designing & developing Test Automation Frameworks
• Responsible to innovate and implement test automation to reduce manual test coverage Partner closely with the Digital System Owners along with software development teams to deliver automation and automated frameworks to ensure products and services work in a fully integrated manner as expected Work with the Biomanufacturing Applications team, Digital Security, Digital Operations, Digital Quality/Quality Systems, Project Management teams, and third-party vendor teams to ensure coverage and consistency in testing Work as part of a team of problem solvers, helping to solve complex business issues from testing strategy to execution Develop and apply a risk-based testing methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 Develop and execute Digital Systems Development Lifecycle (SDLC) approach in support of GxP systems across the Resilience network.
• These include custom software systems, custom technology platforms, COTS configuration systems, cloud infrastructure, and SaaS used in support of GXP operations.
• Collaborate with Digital Quality to maintain a state of control and compliance with established Quality Systems across the network.
• Prioritize the enablement of test automation and efficiency within the SDLC (e.g. requirements, business process maps, test case management, automated regression testing, and traceability) Ensure the IT resilience of our manufacturing operations maintains consistency by driving accountability in the usage of templates for testing artifacts including test plans, test cases, test execution, and summary reports to ensure repeatability and compliance with our GxP and Quality process and standards.
• Design and create automated solutions that cover end to end testing encompassing upgrade, regression, patching, performance, and security Familiarity with tools like Selenium, Robot Framework, Jenkins, XRAY, Micro Focus ALM, Atlassian products, and scripting automation tools
• Experience creating data-driven framework with solid analytical and problem-solving skills Experience working in agile development, CI/CD, data analysis, and data querying skills

Job Type: Contract

Pay: $65.00 - $70.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5: 7 years (Required)
• GxP systems across: 5 years (Required)
• Digital Security, Digital Operations, Digital Quality: 5 years (Preferred)
• Selenium, Robot Framework, Jenkins, XRAY, Micro Focus ALM: 3 years (Required)

Work Location: Remote

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