Validation Engineer

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.

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.
• Able to work in a fast-paced, highly regulated environment with strong attention to detail.