Validation Engineer

Medline Industries LP

Base: $73,000.00 - $110,000.00 annual; bonus/equit...
Not specified
Bachelor of science in biology chemistry or engineering
2 years validation experience in cgmp environment
Iq oq pq execution and documentation
Medline Industries LP is seeking a Validation Engineer to ensure that manufacturing processes for cGMP products comply with regulatory requirements. The role involves validating equipment, managing engineering studies, and supporting change assessments while working independently and collaboratively within a team

Job Summary

  • The role is responsible for validating facility utilities and equipment processes to ensure adherence to cGMP regulatory requirements for pharmaceuticals and medical devices.
  • Candidates will manage revalidation projects, perform engineering studies, and coordinate computer and test method validations while maintaining strict documentation standards.
  • Medline Industries offers a competitive salary range of $73,000 to $110,000 along with comprehensive benefits including health insurance, 401(k) contributions, and paid time off.

Matching Summary

Match Score: 85

Medline Industries LP is seeking a Validation Engineer to ensure that manufacturing processes for cGMP products comply with regulatory requirements. The role involves validating equipment, managing engineering studies, and supporting change assessments while working independently and collaboratively within a team.

Salary

Base: $73,000.00 - $110,000.00 Annual; Bonus/Equity: Bonus and/or incentive eligible; Benefits: Health insurance, life, disability, 401(k), PTO

Skills & Requirements

Must-have

  • Bachelor of Science in Biology Chemistry or Engineering
  • 2 years validation experience in cGMP environment
  • IQ OQ PQ execution and documentation
  • Change control assessment and qualification
  • Root cause investigation for non-conformances

Nice-to-have

  • Masters degree in relevant engineering field
  • Six Sigma certification
  • Experience with ISO 13485 and ISO 11607 standards
  • Proficiency with Minitab statistical analysis software
  • Measurement System Analysis (Gage R&R) expertise

Key Requirements

  • Bachelor of Science Degree required
  • Minimum 2 years cGMP validation experience
  • Experience with FDA regulated environments
  • Strong oral and written communication skills

Work Rights

Not specified

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