Validation Technician

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.

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.

• 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.

• 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.

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.

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.