Equipment Qualification Expert

21 hours ago


Durham, North Carolina, United States KBI BioPharma Full time
Equipment Qualification Expert Job Description">

KBI BioPharma is seeking an experienced Equipment Qualification Expert to join our team. As an Equipment Qualification Expert, you will be responsible for ensuring the qualification of equipment and systems within the Validation Department.


Key Responsibilities:">
  • Ensure the qualification of equipment and systems through planning, development, and execution of life cycle engineering and validation lifecycle documentation elements.
  • Maintain and access the validation documentation archive to fulfill internal/external client and/or auditor requests.
  • Coordinate validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.
  • Conform to all cGMP requirements for documentation and data integrity.

Requirements:">
  • Bachelor's degree in Chemical Engineering, Industrial Engineering, or related scientific field.
  • Three to five years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in the pharmaceutical/biotechnology industries.
  • Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
  • Technical writing and literacy in engineering documentation review/interpretation.

Salary and Benefits:">

The salary range for this position is $70,156 - $96,465 per year. KBI BioPharma offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.


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