Description
FITS is seeking a Senior Quality Engineering Specialist to support pharmaceutical and biologics manufacturing quality initiatives involving assets, utilities, maintenance, engineering, and processes. The role monitors qualified utilities, supports maintenance, engineering, and qualification activities, participates in investigations and root-cause analysis, supports change controls and risk management, and ensures documentation complies with Good Documentation Practices and data-integrity requirements. The position requires a bachelor’s degree in engineering, at least five years of experience in automated bulk pharmaceutical GMP operations, bilingual Spanish and English ability, and availability for 24/7 operations, shift rotations, weekends, holidays, and emergencies.
