Validation Technician

Fagron Nederland BV; Wichita (KS); Presencial; USD 60.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Comprehensive benefits

Performance package

Global opportunities

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Calibration

Documentation

Cross-functional collaboration

Regulatory understanding

Educación

AS degree in technical/engineering/pharma

Herramientas

Kaye AVS

Descripción del empleo

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.