process validation engineer

Key Responsibilities

• 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 lowcapability processes.
• Define and maintain the Process Validation Master Plan (PVMP).
• Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.
• Support pilottoproduction scaleup for new blood glucose sensor manufacturing lines.
• Optimize process parameters for yield, throughput, and quality.
• Lead rootcause 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.

Qualifications Required

• 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.

Preferred

• Experience with blood glucose sensor processes or electrochemical sensor manufacturing.
• Six Sigma Green Belt or Black Belt certification.
• Experience with automated or semiautomated process lines.