Lead Validation Engineer

2 months ago


Carlsbad, United States Bolt Medical Full time
Lead Validation Engineer

Bolt Medical is on the lookout for an experienced Lead Validation Engineer to enhance our dynamic team. The successful candidate will play a pivotal role in formulating and executing comprehensive validation plans to guarantee product excellence and adherence to regulatory standards. If you possess a profound knowledge of validation methodologies, outstanding analytical capabilities, and a talent for effective teamwork, we encourage you to explore this opportunity.

Core Responsibilities:
  • Design and implement validation protocols for systems, processes, and equipment.
  • Ensure alignment with regulatory standards and industry best practices.
  • Develop and uphold validation documentation.
  • Examine data to foster continuous improvement initiatives.
  • Engage with cross-functional teams to devise risk management strategies.
  • Oversee equipment qualification processes.
  • Offer guidance and training to junior validation engineers.
Qualifications:
  • Bachelor's degree in Engineering or a related discipline (Master's degree preferred).
  • 7+ years of validation experience within regulated sectors.
  • Familiarity with FDA, ISO, and other regulatory frameworks.
  • Exceptional analytical and problem-solving abilities.
  • Strong communication and organizational skills.


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