Sr. Validation Engineer, Process Validation

Aldevron

Fargo, United States
Process characterization and validation
Cgmp regulations
Quality by design principles
The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron’s Fargo, ND site

Job Summary

  • The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron’s Fargo, ND site.
  • In this role, you will have the opportunity to Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product.
  • Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron’s Fargo, ND site.

Skills & Requirements

Must-have

  • Process characterization and validation
  • cGMP regulations
  • Quality by Design principles
  • Client and regulatory audits
  • Risk assessment and root cause analysis

Nice-to-have

  • Continuous improvement culture
  • Collaborative spirit
  • Mission-driven team
  • Innovation for tangible impact

Key Requirements

  • Bachelor's degree in Engineering or Scientific field with 5+ years of experience
  • MS degree with 3+ years of experience
  • PhD in Engineering or Scientific field with 2+ years of experience
  • Experience in process development, engineering, and process validation
  • Experience working in CDMO environment is a plus
  • 10% travel

Work Rights

Not specified

Tailored Resume

Cover Letter