ValidationEngineer

## **Job Description** Reports into the Manufacturing engineering function. The Carpinteria site manufactures cancer diagnostic kits that provide patients with trusted answers. The Validation Engineer supports validation and sustaining engineering activities for manufacturing equipment and systems in a regulated IVD environment, with emphasis on automation and controlled temperature systems. **Key Responsibilities** * Execute validation activities across the equipment and software lifecycle, including IQ/OQ/PQ, to support new equipment introduction, changes, and maintenance of the validated state * Author and execute validation protocols and reports in compliance with quality system requirements * Provide direct support to production teams to ensure equipment readiness and sustained compliance, including execution of IQ/OQ activities * Support qualification of automation systems (PLC-controlled equipment, vision systems, labeling platforms), software and controlled temperature/refrigeration units * Support validation of facility and infrastructure changes, including utilities and environmental conditions * Apply statistical sampling best practices and statistical methods to evaluate reliability and product quality * Develop and execute Gage R&R studies for test methods and inspection systems * Contribute to process risk analysis (e.g., FMEA) to identify and mitigate risks * Support supplier evaluation and qualification of materials and components for lifecycle sustaining * This role will work within the Global Operations Manufacturing team to support the site ma activities * Lead quality improvement efforts to reduce department nonconformances, and drive action through continuous improvement or CAPA. * Collaborate cross-functionally with Manufacturing Operations, Process Engineering, MSAT, Quality Assurance, and Regulatory Affairs to support manufacturing design updates, labeling changes, and process improvements ## ## **Qualifications** * Bachelor’s degree in engin