Validation & Verification Engineer in CHIPPENHAM, United Kingdom

Objectives

• Checking on behalf of the next level whether the right product has been developed.
• Demonstrating, by analysis and testing, that the product meets the users' requirements, in particular with respect to safety and quality as well as with emphasis on the suitability of its operation in accordance to its purpose in its intended environment.
Area of responsibility Planning, conducting, and documenting the validation for the project to which the validator has been appointed. The validator:
• shall develop a system understanding of the (sub-)system within the intended environment of application
• shall develop a validation plan and specify the essential tasks and activities for (sub)-system validation and come to an agreement with the assessor the completeness and thoroughness of the validation effort.
• shall review the (sub-)system requirements against the intended environment/use
• shall review the (sub-)system against the functional requirements to ensure all of these are fulfilled
• shall evaluate that the applied process and the developed system conform with the requirements of the required standards, including the assigned SIL
• shall evaluate that the correctness, consistency and adequacy of verification and testing is performed
• shall check the correctness, consistency and adequacy of test cases and executed tests
• shall ensure all validation plan activities are carried out
• shall review and classify all deviations in terms of risk (impact) and records and submits the deviations to the body responsible for Change Management and decision making
• shall give a recommendation on the suitability of the (sub-)system for intended use and indicate any application constraints as appropriate
• shall capture deviations from the validation plan
• shall carry out audits, inspections or reviews on the overall project (as instantiations of the generic development process) as appropriate in various phases of development
• shall review and analyze the validation reports relating to previous applications as appropriate
• shall review that developed solutions are traceable to the (sub-)system requirements
• shall ensure that the related hazard logs and remaining non-conformities are reviewed and all hazards closed out in an appropriate manner through elimination or risks control/transfer measures (only if equipment is safety related)
• shall develop a validation report
• shall approve or disapprove the release of the (sub-)system
3. Main tasks The validation takes place in the form of analysis and tests with (sub-) system and systems. Validation includes checking the requirements for correctness focused on planning, conducting and documenting the validation according to the responsibilities.