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Validation Engineer
Expleo GroupValidation Engineer managing software testing and validation activities in a life sciences context. Collaborating with teams to ensure compliance and produce test documentation.
Tech Stack
Tools & technologiesJavaMySQLOracleSDLCSQL
About the role
Key responsibilities & impact- Engage in software testing and validation activities in a regulated life sciences environment
- Collaborate with project teams to maintain system validation
- Develop and execute test plans and validation protocols
- Produce and review test documentation such as Test Scripts and Validation Summary Reports
- Ensure compliance with regulatory standards
- Manage defect tracking and resolution processes
Requirements
What you’ll need- Minimum 5 to 10 years of experience in software testing/validation in a regulated environment
- Ability to successfully manage multiple tasks and timelines
- Ability to effectively liaise with project team members and other teams/departments, on-site and remotely
- Ability to perform and coordinate activities required to bring/maintain systems to a validated state
- In depth knowledge of Software Development Life Cycle and its major phases
- Proven experience with testing and validation deliverables such as Test/Validation Plan, Test Script Preparation/Execution/Review, Defect Management, Traceability matrix, Validation Summary Report is required
- Proven experience in different types of testing (including but not limited to Black Box Testing, Graphical User Interface (GUI) Testing, System Testing (OQ), User Acceptance Testing (PQ), Functional Testing, Regression Testing, etc.)
- Proven experience in testing applications developed in different programming languages and tools (i.e. Java, .Net, Oracle, MySQL, C++) is preferred
- Proven experience with automated testing, preferably the Katelon tool, required
- Strong knowledge of regulatory guidelines on computerized systems, 21 CFR Part 11, Annex 11, and/or GAMP 5
- Understanding of SQL and database concepts is preferred
- Experience in Test Automation Tools or Application Lifecycle Management is preferred
- Strong organizational and problem solving skills for tasks and functions related to testing and validation of applications
- Strong verbal and written communication skills
Benefits
Comp & perks- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
Software Development Life CycleTest Script PreparationBlack Box TestingGUI TestingSystem Testing (OQ)User Acceptance Testing (PQ)Functional TestingRegression TestingSQLDatabase Concepts
Soft Skills
Organizational SkillsProblem Solving SkillsVerbal CommunicationWritten Communication