Validation Technician

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Performance package

Job summary

Fagron Sterile Services US (FSS) in Wichita is seeking a Validation Technician to execute and document calibration, qualification, and validation activities supporting sterile drug manufacturing. This role requires prior experience in pharmaceutical manufacturing with a strong understanding of cGMP and validation principles.

Candidates must have an AS degree or equivalent experience and knowledge of FDA compliance. The position offers competitive salary and comprehensive benefits within a dynamic and expanding international company.

Qualifications

• 24 years of experience in pharmaceutical or sterile manufacturing, preferably in a 503B facility.
• Knowledge of cGMP and validation principles is essential.
• Strong documentation skills and effective communication abilities.

Responsibilities

• Perform calibration and validation of manufacturing equipment.
• Execute validation protocols and generate compliant reports.
• Support and document compliance with FDA and cGMP regulations.

Skills

Calibration and validation

Documentation skills

Cross-functional collaboration

Education

AS degree in a technical/engineering/pharma discipline

Tools

Validation data acquisition systems

Kaye AVS

Job description

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: Together we create the future of the personalized medicine. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.

About the Job

The Validation Technician executes and documents calibration, 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.
• 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.

Basic Qualifications

• AS degree in a technical/engineering/pharma discipline or equivalent experience.
• 24 years of experience 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 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.