Manufacturing Operations Lead

hace 3 días


Alajuela, Alajuela, Costa Rica Gsb A tiempo completo
Job Summary

Gsb is seeking a highly skilled Manufacturing Operations Lead to join our team. In this role, you will be responsible for guiding the EM on the Validation process, leading the draft and review of protocols and test reports, and offering onsite support at the EM during the execution phase of validations (IQ, OQ, PQ).

The ideal candidate will have 3+ years of experience in the Medical Device Industry, with strong project management skills and knowledge of manufacturing principles and practices. They will also be responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices.

Key Responsibilities:

  • Guide the EM on the Validation process
  • Lead the draft and review of protocols and test reports
  • Offer onsite support at the EM during the execution phase of validations (IQ, OQ, PQ)
  • Draft Validation Strategy, including TMV's
  • Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria

Requirements:

  • 3+ years of experience in the Medical Device Industry
  • Strong project management skills
  • Knowledge of manufacturing principles and practices
  • English Advanced
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