Senior Equipment

3 weeks ago


San Diego CA United States Tek Support Full time

The Senior Equipment & System Specialist will manage the lifecycle of equipment across point-of-care facilities in the US, ensuring compliance and efficient functionality. Initial onboarding and training will be conducted in Belgium (client-funded travel).


Key Responsibilities:

  • Deploy new instruments within Point of Care Manufacturing network
  • Coordinate and oversee instrument qualification and maintenance
  • Ensure data integrity and user management compliance
  • Review vendor documentation (IOQ, PQ) and write lifecycle documents (URS, IQ, OQ, PQ)
  • Conduct root-cause analysis and implement corrective actions for deviations


Qualifications:

  • BSc/MSc in Life Sciences, Biotechnology, Engineering, or related field with 5-10 years of experience
  • Knowledge of cGMP equipment lifecycle requirements, GMP, ICH guidelines, and ATMP regulations
  • Experience with computer system validations (preferred)
  • Strong communication skills; fluent in English
  • US-based, willing to travel up to 50% (key locations: Boston, San Francisco, San Diego)


Attributes:

  • Quality-driven, adaptable to changing priorities, and fosters continuous improvement

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