at Fagron Sterile Services in Wichita, Kansas, United States
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.
Key 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 (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.
