Process Validation Engineer
Diverse Lynx
- Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
- Conduct process characterization using DOE, SPC, and statistical modeling.
- Perform process capability studies (Cp/Cpk) and implement corrective actions for low-capability processes.
- Define and maintain the Process Validation Master Plan (PVMP).
- Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.
- Support pilot-to-production scale-up for new blood glucose sensor manufacturing lines.
- Optimize process parameters for yield, throughput, and quality.
- Lead root-cause analysis and CAPA activities related to process deviations or excursions.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
- Support internal, external, and regulatory audits by providing process validation documentation.
- Work with Manufacturing Engineering and Operations to implement validated processes on the production floor.
- Train technicians and operators on validated processes and control plans.
- Bachelor's degree in Biomedical, Chemical, Mechanical, Industrial, or related Engineering field.
- 3+ years of experience in process validation within a medical device, diagnostics, or biosensor environment.
- Strong knowledge of DOE, SPC, statistical tools (JMP/Minitab), and validation methodologies.
- Understanding of regulated medical device manufacturing and QMS requirements.
- Experience with blood glucose sensor processes or electrochemical sensor manufacturing.
- Six Sigma Green Belt or Black Belt certification.
- Experience with automated or semi-automated process lines.
- Experience in the semiconductor industry for wafer production.
Vacancy posted 12 hours ago
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