Validation Technician

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

About the Job

The Validation Technician executes anddocumentscalibration, 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.
• 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.

Basic 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.
• Effective communication and ability to collaborate cross-functionally.

What's on Offer?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.