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Senior Quality/Process Validation Engineer

2 months ago

Austin, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Evaluate and validate equipment and processes in the development and production of medical products to ensure efficient and compliant operations.
  • uthor, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA/AAMI/ISO/EN guidelines/standards.
  • ctively participate in all phases of process qualification.
  • Evaluate projects, provide guidance and technical information, generate protocols, execute qualification activities, analyse data, and prepare reports.
  • Lead all assigned qualification activities and make independent decisions related to these activities.
  • Participate in the generation and/or updates of the validation plan and validation status lists.
  • Review qualification packages for completeness, accuracy, compliance, and sound rationale.
  • Compare results against acceptance criteria and collaborate with departments to resolve exceptions and deviations.
  • Bring critical exceptions or deviations to management's attention and propose compliant solutions.
  • Lead troubleshooting activities for deviations and non-conformances.
  • Recommend acceptance and release of qualified systems to management.
  • Initiate and enforce improvements and corrections; participate in team meetings relevant to validation.
  • Write and revise standard operating procedures detailing validation principles and activities.
  • Provide training and guidance to operators and technicians.
  • Initiate, execute, and track completion of Change Control requests.
  • Establish priorities and schedules to ensure timelines and milestones are met.
  • Participate in external audits of providers and labs.
  • Ensure systems run according to specifications and operate within regulations to produce quality products.
  • Coordinate with personnel affected by validation testing.
  • Compose validation execution reports and associated deviations.
  • Monitor and test equipment, analyze and document test results, and prepare compliance reports.
  • Direct validation activities, resolve testing problems, and make adjustments or improvements to equipment and processes.
  • Create databases to track validation activities and develop validation schedules.
  • Conduct training and oversee the work of validation technicians.
  • Maintain instrumentation and equipment and stay current on industry standards and regulations.
Requirements:
  • Typically requires a minimum of 6-8 years of experience in process validation or related fields.
  • Knowledge of statistical tools and methodologies.
  • Proficiency with electronic assembly, PCB operations, testing, inspection, and mechanical/electrical tools.
  • Strong office skills, including data entry and proficiency with office software (word processing, spreadsheets, presentations).
  • Demonstrated advanced functional and technical skills, troubleshooting and diagnostic abilities.
  • Leadership skills to mentor other validation engineers and cross-functional teams.
  • Certified Quality Engineer and Six Sigma Green Belt/Black Belt.