What are the responsibilities and job description for the Validation Engineer position at Fagron Sterile Services US (FSS)?
About the Job
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.
Key Responsibilities
- Develop, 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.
Basic Qualifications
- 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.