Senior Equipment Engineer

Kincell Bio

Durham, NC, United States
On-site
Gmp equipment lifecycle management
Urs -> fat/sat -> installation -> release
Cmms calibration system oversight
Kincell Bio engineers cells into therapies with a mission to streamline CMC development, expertise in analytical and process development, and GMP manufacturing, testing, and release

Job Summary

  • Kincell Bio engineers cells into therapies with a mission to streamline CMC development, expertise in analytical and process development, and GMP manufacturing, testing, and release.
  • The Senior Equipment Engineer will own the full lifecycle of GMP equipment, supporting rapid onboarding, qualification, and maintenance while ensuring compliance and enabling scalable manufacturing operations.
  • The company offers challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

Matching Summary

Kincell Bio engineers cells into therapies with a mission to streamline CMC development, expertise in analytical and process development, and GMP manufacturing, testing, and release.

Skills & Requirements

Must-have

  • GMP equipment lifecycle management
  • URS -> FAT/SAT -> installation -> release
  • CMMS calibration system oversight
  • IQ/OQ protocol drafting and execution
  • Cross-functional team collaboration
  • Vendor contact for maintenance and calibration

Nice-to-have

  • Fast-paced startup environment
  • Independent work capability
  • Business acumen and ethics
  • Flexible working hours

Key Requirements

  • Minimum 3 years GxP validation/engineering/calibration
  • Bachelor's degree in engineering or equivalent
  • 3-8+ years GxP experience preferred
  • Graduate degree in Engineering preferred

Work Rights

Not specified

Tailored Resume

Cover Letter