Senior Engineer, Validation

Role: Senior Validation Engineer responsible for developing, executing, and maintaining validation activities at Indivior’s Raleigh, NC site, ensuring compliance with FDA and global regulations. Objectives include qualification/requalification of equipment and processes, validation of manufacturing and utility systems, and continuous improvement of validation practices. Responsibilities encompass authoring validation protocols (IQ/OQ/PQ), executing validation/qualification activities, managing validation documentation, and overseeing change controls, deviations, and investigations. The role also involves risk assessment, regulatory interactions, and validating GMP equipment and systems, including aseptic areas, process equipment, and environmental chambers. Requirements: Bachelor's in science or engineering; minimum five years’ experience in production, engineering, or quality control within GMP environments; proficiency in validation methodologies, GAMP, CFR Part 11, and data integrity standards. Preferred: experience developing protocols for laboratory instruments used in QC testing, knowledge of quality tools like FMEA and Six Sigma, and familiarity with automation and computer system validation. The position involves cross-functional collaboration with manufacturing, quality, and compliance teams, with a focus on GMP/GxP adherence. Work setup is onsite in Raleigh, NC, with no explicit travel requirements specified.