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Validation Engineer

1 month ago

Lexington, Kentucky, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Validation Engineer - Process Validation to join our team in Lexington, MA. As a key member of our biologics manufacturing operations, you will be responsible for providing validation support for our cell culture, purification, mixing, and chromatography/membrane lifetime processes.

Key Responsibilities
  • Author and execute validation protocols and reports for biologics manufacturing operations
  • Perform data analysis and compilation of data and results into summary and final reports
  • Align manufacturing processes with executed validation
  • Participate in regulatory inspections and identify opportunities for continuous improvements
  • Represent validation at Lexington Site Work System meetings and support/maintain the validation communications board and community of practice
Requirements
  • Bachelor's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 5 years of related experience
  • Master's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 3 years of related experience
  • PhD degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 0 years of related experience
Preferred Skills
  • Working knowledge of the science and technology for the major unit operations associated with manufacturing operations
  • Excellent written and verbal communication skills
  • Ability to work independently in a fast-paced environment and manage multiple projects and priorities
What We Offer
  • Competitive compensation and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment

We are an equal opportunity employer and welcome applications from diverse candidates. Please reference job #R when applying.