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Validation Director

2 months ago

Uppsala, Uppsala, Sweden Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled and experienced Validation Leader to join our team at Thermo Fisher Scientific. As a key member of our organization, you will be responsible for leading validation activities, including planning, strategy development, and documentation.

Key Responsibilities
  • Lead project teams for new investments and production changes, ensuring seamless integration and compliance with regulatory requirements.
  • Develop and implement validation strategies, including risk assessments and qualification plans.
  • Coordinate the implementation of validation, qualification, and commissioning activities, ensuring timely completion and quality results.
  • Conduct requirements definition, risk analyses, and periodic reviews to ensure ongoing compliance and improvement.
  • Lead and coordinate independent activities throughout the validation process, ensuring objectivity and thoroughness.
  • Review and release validation documents, ensuring accuracy and completeness.
  • Develop and implement internal routines, work processes, and training programs to ensure knowledge sharing and skill development.
Requirements
  • Minimum 2 years of experience in the medical device or pharmaceutical industry, with a strong background in validation and quality assurance.
  • Proven experience as a Validation Leader or Validation Engineer, with a track record of successful project delivery and compliance.
  • Technical or scientific university education, with a strong foundation in quality assurance and regulatory compliance.
  • Excellent knowledge of validation work, including risk management and statistical tools.
  • Strong communication and leadership skills, with the ability to collaborate with cross-functional teams and stakeholders.
What We Offer

At Thermo Fisher Scientific, we value teamwork, quality, and the exchange of experience. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.