QA Validation Engineer

As a QA Validation Engineer, you will play a critical role in ensuring the compliance and validation of the facilities, utilities, equipment, and processes according to regulatory requirements. Your expertise will be essential in reviewing and approving validation documentation, developing validation strategies, and maintaining the validated state of our operations.

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  Validation and Qualification Maintenance:
  • Contribute to maintaining the validated state of facilities, utilities, equipment, and processes.
  • Ensure all activities comply with relevant regulatory requirements and internal quality standards.
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  Document Review and Approval:
  • Review and approve validation and qualification documents, including validation plans, protocols, final reports, risk assessments, and user requirement specifications.
  • Provide technical and quality expertise during the review process to ensure compliance and accuracy.
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  Validation Strategy Development:
  • Participate in the development of qualification and validation strategies for new and existing projects.
  • Collaborate with cross-functional teams to align validation activities with overall project goals and regulatory expectations.
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  Equipment and Process Validation:
  • Review and approve protocols and reports related to the initial qualification, periodic requalification, and revalidation of equipment, clean rooms, laboratories, and utilities.
  • Oversee validation activities for sterilization, manufacturing, filling, cleaning, and depyrogenation processes.
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  Quality Metrics and Continuous Improvement:
  • Maintain and update quality indicators related to qualification and validation processes.
  • Review and approve deviations identified during protocol execution and ensure proper resolution.
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  Risk Analysis:
  • Participate in risk analyses for equipment and processes, ensuring that all potential risks are identified, assessed, and mitigated appropriately.

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Proven experience in a QA Validation role within the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of regulatory requirements and standards
• Experience in reviewing and approving validation documents.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in cross-functional teams.
• Strong communication and documentation skills.
• Fluency in French and English.