Process Validation Specialist

vor 2 Wochen


Genf, Genf, Schweiz Michael Page Vollzeit
Job Description

Michael Page is seeking a highly skilled Process Validation Engineer to join our team.

Key Responsibilities
  • Collaborate with cross-functional teams to ensure seamless transfer of new products from design to production.
  • Develop and implement process validation plans in accordance with regulatory requirements.
  • Conduct equipment qualification, sterilization, and cleaning validation activities.
  • Ensure the maintenance of validated statuses for equipment and processes.
  • Contribute to the development of validation protocols and participate in the continuous assessment and optimization of manufacturing processes.
  • Identify and assess risks associated with manufacturing processes and develop strategies to mitigate these risks.
  • Represent the validation department during inspections and audits by regulatory agencies.
Requirements
  • Degree in medical technology, engineering, or a related field.
  • Fluency in English.
  • First experience in industrialization and validation within the medical device industry.
  • Strong knowledge of ISO 17665-1, ISO 13485, and ISO 14971.
  • Excellent computer skills.
Personal Qualities
  • Strong ethics, creativity, and problem-solving abilities.
  • Proactive and able to initiate and self-start projects.
  • Positive, flexible, and resilient with excellent planning, communication, and presentation skills.


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