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Validation Engineer
Validation EngineerKatalyst CRO • Gainesville, FL, US
Validation Engineer

Validation Engineer

Katalyst CRO • Gainesville, FL, US
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  • 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 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.
  • process improvements and equipment modifications.

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 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.
  • process improvements and equipment modifications.

    • 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.

    • Seniority level

    Seniority level

    Mid-Senior level

    Employment type

    Employment type

    Contract

    Job function

    Industries

    Pharmaceutical Manufacturing

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