Manufacturing Engineer / validation process engineer

cGxPServeGainesville, FL, United States

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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.

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

Strong understanding of FDA, ISO 13485, and GMP requirements.

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

Experience with QMS systems and documentation practices.

Excellent analytical, problem-solving, and communication skills.

Validation Engineer • Gainesville, FL, United States