Process Validation Engineer

We are seeking a Process Validation Engineer with hands-on experience in Test Method Validation (TMV) within a regulated manufacturing environment. The role will be responsible for leading TMV remediation activities, executing validation protocols, analyzing results, and ensuring validation activities are completed in accordance with quality-system requirements. Key Responsibilities Lead and execute Test Method Validation (TMV) and remediation activities. Develop, review, execute, and support the approval of TMV protocols and final validation reports. Plan and perform validation testing, including sample preparation, test method execution, and data collection. Analyze validation results and document findings, deviations, and issues identified during execution. Apply statistical methods, including Gage R&R, to assess test method capability and support validation conclusions. Troubleshoot validation issues and collaborate with relevant teams to identify and implement effective resolutions. Support operator training to ensure consistent and compliant execution of validated test methods. Partner cross-functionally with Engineering, Quality, Manufacturing, and other stakeholders to complete validation activities. Maintain accurate validation records and documentation in accordance with quality-system and regulatory requirements. Track TMV remediation activities and timelines and drive assigned activities through successful completion. Support continuous improvement of manufacturing and validation processes as needed. Required Qualifications & Experience Hands-on experience with Test Method Validation (TMV) activities. Experience with the complete validation lifecycle, including protocol development, execution, data analysis, and final reporting. Strong knowledge of statistical analysis, including Gage R&R and measurement system analysis (MSA). Experience working in a regulated manufacturing environment, preferably within the medical device industry. Strong technical writing, documentation, and validation report-writing skills. Ability to independently plan and execute validation activities while meeting established timelines. Experience working collaboratively with Engineering, Quality, Manufacturing, and Operations teams. Strong analytical, organizational, problem-solving, and communication skills.