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Validation Technician

United States, Wichita · Job Posted April 05, 2026
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Job Description

The Validation Technician executes and documents calibration, qualification, and validation activities that support sterile drug manufacturing within a 503B outsourcing facility. This role ensures equipment, utilities, and controlled environments operate in compliance with FDA, cGMP, and data integrity requirements.

Job Responsibility

  • Perform calibration, qualification (IQ/OQ/PQ), and routine requalification of manufacturing equipment, utilities, and critical instruments
  • Execute approved validation protocols and generate compliant final reports
  • Support validation lifecycle activities, including risk assessments and periodic reviews
  • Operate and maintain validation data acquisition systems (e.g., Kaye AVS)
  • Document all activities according to ALCOA+ data integrity principles
  • Maintain calibration/validation databases with NIST traceability
  • Coordinate external contractors for cleanroom certification
  • Troubleshoot and perform minor repairs on instruments and equipment
  • Ensure compliance with 21 CFR Parts 210/211 and internal quality systems
  • Support investigations with technical data and root cause analysis

Requirements

  • AS degree in a technical/engineering/pharma discipline or equivalent experience
  • 2–4 years experience in pharmaceutical or sterile manufacturing
  • 503B preferred
  • Knowledge of cGMP, validation principles, cleanroom operations, and aseptic processing
  • Familiarity with USP, ISPE, PDA, and FDA sterile compounding guidance
  • Strong documentation skills in regulated environments
  • Effective communication and ability to collaborate cross-functionally

What we offer

  • competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry

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