Sterile Validation Technician - IQ/OQ/PQ Specialist

Fagron Nederland BV; Wichita (KS); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Performance package

Global opportunities

Job summary

Fagron US is seeking a Validation Technician to execute and document calibration, qualification and validation activities that support sterile drug manufacturing in a 503B facility. You will ensure equipment and cleanrooms operate in compliance with FDA, cGMP, and data integrity requirements.

Responsibilities include performing IQ/OQ/PQ, maintaining validation data systems, generating final reports, and coordinating with contractors for cleanroom certification.

Qualifications

• AS degree ina technical/engineering/pharma discipline or equivalent experience.
• 2–4years experiencein pharmaceutical or sterile manufacturing; 503B preferred.
• Knowledge of cGMP, validation principles, cleanroom operations, and aseptic processing.
• Familiarity with USP, ISPE, PDA, andFDAsterile compounding guidance.
• Strong documentation skills in regulated environments.

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.
• Supportvalidationlifecycle activities, including risk assessments and periodic reviews.
• Operate andmaintainvalidationdata 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.

Skills

Calibration

Documentation

Cross-functional collaboration

Regulatory understanding

Education

AS degree in technical/engineering/pharma

Tools

Kaye AVS

Job description

Fagron US is seeking a Validation Technician to execute and document calibration, qualification and validation activities that support sterile drug manufacturing in a 503B facility. You will ensure equipment and cleanrooms operate in compliance with FDA, cGMP, and data integrity requirements.

Responsibilities include performing IQ/OQ/PQ, maintaining validation data systems, generating final reports, and coordinating with contractors for cleanroom certification.