Validation Scientist Cleaning & Sterilization

Eli Lilly and Company

Research Triangle Park, North Carolina, United States
Base: $66,000 - $171,600; bonus/equity: compyny bo...
Cgmp regulatory compliance knowledge
Validation protocol development and execution
Sterilization methodology expertise
This role is critical for ensuring the safety, efficacy, and quality of pharmaceutical products at a state-of-the-art facility in North Carolina

Job Summary

  • This role is critical for ensuring the safety, efficacy, and quality of pharmaceutical products at a state-of-the-art facility in North Carolina.
  • The successful candidate will lead validation studies for cleaning, sterilization, and temperature mapping while ensuring strict adherence to cGMP and FDA guidelines.
  • Lilly offers a comprehensive benefit program including medical, dental, vision, 401(k), pension, and wellness benefits alongside a competitive salary range.

Matching Summary

This role is critical for ensuring the safety, efficacy, and quality of pharmaceutical products at a state-of-the-art facility in North Carolina.

Salary

Base: $66,000 - $171,600; Bonus/Equity: Company bonus eligible based on performance; Benefits: Comprehensive program including 401(k), pension, medical, dental, vision, and wellness.

Skills & Requirements

Must-have

  • cGMP regulatory compliance knowledge
  • validation protocol development and execution
  • sterilization methodology expertise
  • temperature mapping study support
  • root cause investigation skills

Nice-to-have

  • statistical analysis for process improvement
  • cross-functional team leadership
  • experience with parenteral drug products
  • audit preparation and support

Key Requirements

  • BS or MS in Microbiology, Biology, Biochemistry, or Engineering
  • 3-5 years experience in pharmaceutical or biotechnology industry
  • Direct experience in cleaning and sterilization validation
  • In-depth knowledge of 21 CFR Parts 210, 211, and EU GMP Annex 15

Work Rights

Not specified

Tailored Resume

Cover Letter