Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Provides validation support for new releases and modifications to applications throughout the software development life cycle. Prepares validation plans, test cases and validation summary reports, and executes test cases.
Reviews and approves all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP.
Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.
Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software functions correctly. Creates, updates, and manages sufficient data within the testing environment to accurately test software functionality. Works with leadership to address any PQ related issues arising from client or internal audits.
Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.
Participates in the identification of user requirements and system design and assists in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years)