Validation Engineer

Who We Are

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 Engineer is responsible for executing and maintaining validation programs that ensure facilities, equipment, utilities, and processes remain in a compliant, validated state within a 503B sterile manufacturing environment. This role supports new and existing operations through protocol development, data analysis, deviation management, and continuous improvement of validation lifecycle activities.

• Create, execute, and maintain validation documents (IQ/OQ/PQ, PPQ, APS, CCIT, cleaning validation, equipment qualification, utility qualification).
• Ensure validation activities comply with FDA 503B guidance, cGMPs (21 CFR Parts 210/211), and industry standards (USP /​, ISPE, PDA).
• Serve as validation SME for operations, engineering, quality, and new product introduction.
• Conduct and document validation‑related investigations, including deviations, OOS, OOT, change controls, impact assessments, and CAPA root‑cause analyses.
• Manage periodic review, revalidation, and continued process verification activities.
• Maintain calibration and preventative maintenance compliance for critical equipment and utilities.
• Support introduction of new equipment, closed systems, and aseptic technologies (e.g., single‑use systems, isolators, automated filling systems).
• Analyze validation data using appropriate statistical tools and prepare clear technical reports.
• Participate in regulatory inspections and defend validation lifecycle documentation.
• Stay current with regulatory expectations, emerging risks, and sterile compounding best practices.

• Bachelor’s degree in Engineering or a scientific discipline (or equivalent experience).
• 2–5 years of validation experience in pharmaceutical, sterile manufacturing, or 503B compounding.
• Strong understanding of aseptic processing, cleanroom classification, equipment/utility systems (HVAC, WFI/PW, compressed gases), and sterile filling operations.
• Experience with cGMP documentation, risk assessments, change control, and CAPA systems.
• Proficient in technical writing, data analysis, and cross‑functional collaboration.
• Ability to work in a fast‑paced, highly regulated environment with strong attention to detail.

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.