We are looking for a highly experienced Lead Validation Engineer to lead the validation of capital equipment and develop the overall validation and qualification plan/strategy. The ideal candidate will have a strong background in process/equipment validation, automation process validation, and CSV knowledge.
The role involves creating the master validation plan, validation strategy, and validation output document, as well as supporting the transition from manual to automated validation methodologies. The candidate will also be responsible for leading the overall validation & qualification of equipment and processes, developing quality validation process flow, and promoting a common approach to documentation and strategies.
The successful candidate will have a strong understanding of CSV processes, including risk-based approaches, qualification testing, validation protocols, and traceability matrix development. They will also have experience with system integration & interface testing, software testing, and documentation & reporting.