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.