Validation Engineer

Company : Katalyst Healthcares & Life Sciences

Job Description:

• 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.

Responsibilities:

• Experience working in QMS and ERP systems.
• Experience with IQ/OQ/PQ/TMV preferred.
• Worked with cross functional teams.
• Collaborate with Quality Engineering to provide manufacturing support.
• Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
• Should be experienced in Medical device manufacturing assembly lines.
• Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
• Need to conduct qualification, verification, and validation activities to produce medical devices.
• Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.
• Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
• Work with CFT teams in troubleshooting problems on the production floor.

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.

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