Validation Technician — GMP, Cleanroom & Data Integrity

Fagron Tech; Wichita (KS); On-site; USD 65,000 - 90,000; Full time

Job summary

Fagron US is seeking a Validation Technician to execute and document calibration, qualification (IQ/OQ/PQ), and validation activities that support sterile drug manufacturing in a 503B facility. The role ensures equipment, utilities, and controlled environments comply with FDA, cGMP, and data integrity requirements.

You will work with cross-functional teams, maintain ALCOA+ data integrity, manage validation data systems such as Kaye AVS, and assist with risk assessments, investigations, and

Qualifications

• AS degree in technical/engineering/pharma field or equivalent.
• 2–4 years 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 and ability to collaborate cross-functionally.

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.

Skills

2–4 years experience

Cross-functional collaboration

Documentation skills

cGMP knowledge

Calibration/validation

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 (IQ/OQ/PQ), and validation activities that support sterile drug manufacturing in a 503B facility. The role ensures equipment, utilities, and controlled environments comply with FDA, cGMP, and data integrity requirements.

You will work with cross-functional teams, maintain ALCOA+ data integrity, manage validation data systems such as Kaye AVS, and assist with risk assessments, investigations, and