Validation Technician

Fagron•Wichita, KS

About The Position

The Validation Technician executes and documents calibration, qualification, and validation activities that support sterile drug manufacturing within a 503B outsourcing facility. The role ensures equipment, utilities, and controlled environments operate in compliance with FDA, cGMP, and data integrity requirements. The position includes carrying out equipment and instrument calibration and qualification, executing approved protocols and preparing final reports, supporting validation lifecycle activities, maintaining validation records and systems, coordinating cleanroom certification contractors, and assisting with troubleshooting, repairs, and investigations.

Requirements

Associate degree in a technical, engineering, or pharmaceutical discipline, or equivalent experience.
2–4 years of experience in pharmaceutical or sterile manufacturing.
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 skills and ability to collaborate cross-functionally.

Nice To Haves

503B experience preferred.

Responsibilities

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 such as Kaye AVS.
Document activities according to ALCOA+ data integrity principles.
Maintain calibration and 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.