Sr. Validation Engineer, Process Validation

Aldevron

Fargo, ND, US
**
Bachelor's degree in engineering or scientific field
5+ years experience in process development
Experience with cgmp regulations
** Aldevron is seeking a Senior Validation Engineer for Process Validation in Fargo, ND, focusing on maintaining validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products. The role requires significant expertise in process validation, mentoring, and compliance with regulatory standards, offering an opportunity to impact the life sciences sector. **

Job Summary

  • The role involves leading the development, execution, and implementation of validation practices across biological critical starting materials, drug substances, and drug products.
  • Candidates will serve as a subject matter expert during client and regulatory audits while resolving quality issues through root cause analysis and CAPAs.
  • The position offers the opportunity to mentor junior associates and contribute to a mission-driven team advancing genomic medicine innovations.

Matching Summary

Match Score: 75

** Aldevron is seeking a Senior Validation Engineer for Process Validation in Fargo, ND, focusing on maintaining validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products. The role requires significant expertise in process validation, mentoring, and compliance with regulatory standards, offering an opportunity to impact the life sciences sector. **

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering or Scientific field
  • 5+ years experience in process development
  • Experience with cGMP regulations
  • Knowledge of Quality by Design principles
  • Root cause analysis and CAPA implementation

Nice-to-have

  • CDMO environment experience
  • Statistical risk assessment tools
  • Leadership and mentoring skills
  • Client and regulatory audit support
  • Danaher Business System knowledge

Key Requirements

  • Bachelor's degree with 5+ years experience OR MS with 3+ years OR PhD with 2+ years
  • Required experience in process development, engineering, and process validation
  • On-site work requirement in Fargo, ND

Work Rights

Not specified

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