Job Description

• Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment.
• Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits.
• Establish preventive maintenance plans, calibration schedules, and critical spare parts lists.
• Author validation plans, validation protocols, test reports, including deviations and corrective actions and Standard Operating Procedures (SOPs).
• Utilize tools such as Minitab to analyze large datasets from sensor builds, performing Design of Experiments (DOE) and process capability studies.
• Perform equipment risk assessments, including pFMEA and hazard analysis.
• Define User Requirements Specifications (URS) for new equipment and lead equipment installation and commissioning efforts.
• Train technicians and operators on validated equipment procedures.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
• Partner with R&D, Quality Assurance, and external vendors to scale up pilot lines to high-volume production.
• Work with Manufacturing Engineers to improve equipment reliability and throughput.
• Support internal and external audits by providing equipment validation evidence.

• Bachelor's degree in mechanical, Electrical, Industrial, Biomedical Engineering, or a related field.
• 3+ years of equipment validation experience within medical device manufacturing.
• Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements.
• Familiarity with automated equipment, robotics, PLCs, and machine vision systems.

• Prior experience validating equipment for biosensor or electrochemical sensor manufacturing, or experience in the semiconductor industry for wafer production.
• Experience with high-speed automation and semi-automated production lines.
• Certification in equipment validation or GAMP 5 training.

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