Validation Process Engineer

Katalyst HealthCares & Life SciencesGainesville, FL

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Responsibilities :

Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.
Process Audits & Documentation : Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.
Process Optimization : Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM. Establish and document robust process parameters and operating windows.
Validation Execution : Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ, OQ, PQ reports based on validation activities.
Statistical Analysis : Run statistical reports to analyze process capability, variability, and performance trends.
Change Management : Lead and document change management activities related to process improvements and equipment modifications.
Continuous Monitoring : Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.

Requirements :

Bachelor's or master's degree in mechanical engineering, Biomedical Engineering, or related field.

years of experience in medical device manufacturing, with hands-on experience in CNC Machining and DCM.

Strong understanding of FDA, ISO , and GMP requirements.

Proficiency in statistical analysis tools (, Minitab, JMP).

Experience with QMS systems and documentation practices.

Excellent analytical, problem-solving, and communication skills.

Validation Engineer • Gainesville, FL