Instrument Validation Engineer
Quotient
Eysins, Switzerland
vor 7 Tg.

Job Description

  • Develop, document and execute validation protocols
  • Determine revalidation requirements through Risk Assessment
  • Manage all validation and qualification activities for the MosaiQ™ instruments
  • Prepare associated reports and work progress updates
  • Maintain the validated state of the instrument in the lab including maintenance / cleaning activities of analysers on a routine basis
  • Define and implement Standard Policies and Procedures for instrumentation maintenance and Quality Control
  • Review R&D protocols and reports to ensure scientific and quality objectives are achieved
  • Be the interface between Instrument validation and all other necessary functions to ensure issues identified during validation are communicated effectively and managed to closure, meeting compliance and timeline needs
  • Complete root cause investigations for non-conformances and deviations associated with the validation activities and identify and implement corrective actions as required
  • Ownership and support of Corrective / Preventative Actions activities driven by the Quality system as required within the remit of work completed
  • Qualifications

  • Master degree or equivalent diploma in Engineering, Science or related discipline
  • Minimum 3 years validation experience in a regulated environment (e.g. medical device / pharmaceutical industry)
  • Experience within a R&D development environment with knowledge of Design control processes
  • A first-hand experience of audits by regulatory authorities is required
  • Excellent decision-making ability and organisation skills
  • Ability to self-manage and prioritise works based on project end date, thus ensuring projects delivered to schedule and budget
  • Willingness and ability to collaborate with and influence other groups in a positive, team based environment
  • Ability to communicate effectively both verbally and written in English and French
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