Principal Validation Specialist

1 week ago


Carlsbad, United States Bolt Medical Full time
Principal Validation Specialist

Bolt Medical is on the lookout for a talented Principal Validation Specialist to enhance our engineering team. The successful candidate will play a crucial role in crafting and executing comprehensive validation frameworks that uphold product excellence and regulatory adherence. If you possess a profound knowledge of validation methodologies, exceptional analytical capabilities, and a collaborative spirit, we invite you to explore this opportunity with us.

Key Responsibilities:
  • Design and implement validation plans for systems, processes, and equipment.
  • Ensure alignment with regulatory standards and industry best practices.
  • Maintain and oversee validation documentation.
  • Utilize data analysis to foster continuous improvement efforts.
  • Work alongside cross-functional teams to develop risk management strategies.
  • Lead initiatives for equipment qualification.
  • Offer guidance and support to junior validation engineers.
Requirements:
  • Bachelor's degree in Engineering or a related discipline (Master's degree preferred).
  • Over 7 years of validation experience within regulated sectors.
  • Familiarity with FDA, ISO, and other relevant regulatory frameworks.
  • Strong analytical and problem-solving aptitude.
  • Outstanding communication and organizational skills.


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