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.