Validation Technician

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

Benefits offered by this job

Competitive salary

Comprehensive benefits

Job summary

Fagron US seeks a Validation Technician to execute and document calibration, qualification, and validation activities in a 503B outsourcing setting. The role ensures equipment, utilities, and clean environments meet FDA and cGMP data integrity standards.

You will perform IQ/OQ/PQ, support risk assessments and periodic reviews, manage data systems, and keep meticulous documentation to maintain compliance across operations and investigations.

Qualifications

• AS degree in technical/engineering/pharma or equivalent experience.
• 2–4 years in pharmaceutical or sterile manufacturing; 503B preferred.
• 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 cross-functional collaboration.

Responsibilities

• Perform calibration, qualification (IQ/OQ/PQ), and requalification of manufacturing equipment and 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 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

Documentation

Cross-functional collaboration

Regulatory compliance

Communication skills

Aseptic processing

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.