About this role

Position: Process Validation Engineer

Location: Northridge, CA-On Site

Duration: 12+ Months Contract

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.
7+ 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.