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Senior Validation Engineer

alcon · Fort Worth

Senior 🇬🇧 English
validation protocols risk assessment audit support change control documentation process qualification aseptic process management

Job description

About the role

Alcon is seeking a Senior Validation Engineer to lead validation and qualification activities across processes, equipment, systems, and facilities. You will work within the Engineering function to ensure compliance with regulatory standards and support continuous improvement of product quality.

Key responsibilities

  • Plan, execute, and document validation studies for equipment, systems, and processes.
  • Conduct risk assessments, design protocols, analyze data, and prepare validation and qualification reports.
  • Support aseptic process management and review/approve change control documentation.
  • Provide audit support and collaborate with cross‑functional teams to solve problems and drive innovation.
  • Author complex validation protocols, perform process qualification for new equipment and technologies, and participate in product transfers and launches.
  • Handle deviations, update documents as needed, and ensure strict adherence to GxP regulations and SOPs.

Required profile

  • Bachelor’s degree in a relevant field or equivalent experience.
  • Minimum 2 years of experience in validation, qualification, or related engineering activities.
  • Fluent written and spoken English.
  • Ability to work independently and make decisions within assigned scope.

Required skills

  • Validation protocol development and execution.
  • Risk assessment and mitigation.
  • GxP compliance and SOP adherence.
  • Aseptic process management.
  • Change control review and approval.
  • Audit support and documentation control.
  • Process and equipment qualification.

Questions fréquentes

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Source : ats:workday

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Published 1 week ago

Expires 1 month from now

8 views · 0 interested

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alcon

Fort Worth