Equipment and Process Validation Specialist

2 weeks ago

Austin, Texas, United States Katalyst Healthcares and Life Sciences Full time

Role Overview:
As a Validation Engineer at Katalyst Healthcares and Life Sciences, you will play a critical role in ensuring that all equipment, software, and processes utilized in the development and manufacturing of medical products meet stringent regulatory and internal standards.

Key Responsibilities:

  • Develop and implement comprehensive validation strategies and requirements.
  • Review and authorize validation documentation, including master validation plans and protocols, to support process validation and re-validation for new product introductions and ongoing projects.
  • Engage actively in all stages of process qualification, providing expert guidance and technical support.
  • Analyze project data, generate protocols, and prepare detailed reports based on qualification activities.
  • Lead and facilitate all assigned qualification tasks, ensuring compliance with applicable FDA, AAMI, ISO, and EN standards.
  • Establish requirements for qualification activities and make informed decisions regarding validation processes.
  • Contribute to the creation and updates of validation plans and status documentation.
  • Ensure the completeness and accuracy of qualification packages, adhering to validation policies and procedures.
  • Address any exceptions or deviations by collaborating with relevant departments to find compliant solutions.
  • Oversee troubleshooting efforts for deviations and non-conformances, recommending actions for system acceptance and release.
  • Initiate and implement necessary improvements and corrections, participating in validation-related team meetings.
  • Draft and revise standard operating procedures that outline validation principles and practices.
  • Provide training and mentorship to operators and technicians involved in validation processes.
  • Manage Change Control requests from initiation through to completion.
  • Prioritize and schedule validation activities to meet established timelines and milestones.
  • Participate in external audits of suppliers and laboratories to ensure compliance with standards.
  • Verify that all systems operate within required specifications and regulations to maintain product quality.
  • Establish validation standards and coordinate with personnel impacted by validation testing.
  • Review and approve validation execution reports, addressing any associated deviations.
  • Analyze test results and prepare compliance documentation.
  • Direct validation activities and resolve any testing challenges that arise.
  • Implement adjustments or enhancements to equipment and processes as necessary.
  • Create and maintain databases to track validation activities effectively.
  • Interpret customer requirements and develop validation schedules accordingly.
  • Conduct training sessions and oversee the work of validation technicians.
  • Stay informed on industry standards and regulatory changes to ensure ongoing compliance.

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