Senior Validation Engineer Medical Devices

2 weeks ago

Irving, Texas, United States BEPC Inc. Full time
Job Title: Senior Validation Engineer Medical Devices

BEPC Inc. is seeking a highly skilled Senior Validation Engineer Medical Devices to join our team of consultants in Irving, TX.

Job Summary:

This role is responsible for managing plant-wide facilities changes at Mentor, Irving Texas, ensuring no disruption to current process/operations.

Key Responsibilities:
  • Ensure current and future manufacturing operations are not disrupted during upgrades.
  • Manage all contractors performing work at the site.
  • Develop and lead execution of validation protocols.
  • Provide support in work instructions and test methods as required by the introduction of new equipment/manufacturing flows.
  • Support training for protocols, new/updated work instructions, and/or test methods.
  • Lead and support prototyping builds for new product introductions.
  • Participate in the design of new equipment and assembly tools required for introduction of new products.
  • Contribute to the development and design of new manufacturing processes.
  • Conduct root cause investigations and write technical reports.
  • Recommend changes to standard operational and working practices.
  • Prepare and maintain accurate documentation for adherence to GMP, FDA, and ISO regulations.
  • Support the stabilization process for the introduction of new products.
  • Perform laboratory testing for development and validation activities for the introduction of new products.
Requirements:
  • A minimum of 5-7 years of experience in the Medical Industry.
  • Bachelor's Degree in Mechanical Engineering, Industrial, Electric/Electronic, or equivalent combination of education.
  • Masters degree preferred.
  • Competent communication skills, both written and verbal.
  • Demonstrated knowledge and experience in Plant-wide project management.
  • Knowledge and experience in IQ/OQ/PQ activities.
  • Good organizational skills and the ability to handle multiple tasks.
  • Strong computer background (MS Office, PowerPoint, Word, Excel, Outlook, etc.).
  • Experience in GMP industry.
  • Experience in performing non-conformance root cause investigation.
  • Lean manufacturing/Six Sigma Process Excellence experience preferred.

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