As a validation project engineer you define the validation approach, create test protocols, create verification and validation documents, execute tests.
The Project Engineer is responsible to solve and document deviations and actions (CAPA’s, risk assessments, CGMP review, new document versions).
- Design, construction and follow up of production equipment
- Guarantees good project management practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, …)
- Keeps oversight of the contractor company that will build, install or test the equipment
- Is responsible for transfer to operations of own equipment, delivering all project documentation and close out of the project
- Follows start up results to guarantee that the project deliverables were achieved
- Defining and executing the engineering tests, verification and validation of own equipment.