HI
HI Validation Engineer
Brighton, MI
Establish validation and qualification criteria for products and systems based on specifications and regulatory requirements.
- Develop, review, and execute validation master plans and protocols (for example DVPRs, test plans, and traceability).
- Create and run tests to evaluate system performance, capability, and repeatability against approved protocols.
- Oversee calibration, verification, and maintenance of instruments and equipment used in validation activities.
- Analyze test data using appropriate statistical methods and summarize results in validation reports with clear conclusions and recommendations.
- Identify deviations, nonconformances, and risks; lead or support root cause investigations and implementation of corrective and preventive actions (CAPA).
- Maintain validation documentation including protocols, reports, risk assessments, traceability matrices, and activity logs in accordance with quality system requirements.
- Ensure systems remain in a validated state through periodic review, revalidation, and change control support.
- Collaborate with engineering, quality, manufacturing, IT, and suppliers during design, commissioning, and qualification of new or modified equipment and processes.