Pharmaceutical Validation Specialist

Lead pharmaceutical validation activities using cGMP expertise and qualification documentation skills across equipment, systems, utilities, and manufacturing operations.The Validation Specialist develops, coordinates, and executes qualification activities for pharmaceutical manufacturing. This role supports regulatory compliance through protocol development, validation reporting, and cross-functional collaboration. Responsibilities include equipment, computerized systems, laboratory instruments, utilities, cleaning processes, and manufacturing operations.Key Responsibilities:
Lead annual performance qualifications for sterilization and depyrogenation equipmentDevelop protocols with critical parameters and acceptance criteriaExecute equipment, systems, utilities, and laboratory instrument qualificationsAssess changes and determine revalidation requirements for validated systemsManage projects according to timelines and the Validation Master PlanRequirements:
Bachelor's degree in Engineering or ScienceMinimum three years of pharmaceutical manufacturing experienceExperience writing qualification documentation and engineering studiesKnowledge of cGMP and Good Documentation PracticesProficiency with Microsoft Office and Kaye Validator softwareApply validation expertise, cGMP knowledge, and qualification experience to pharmaceutical equipment, systems, utilities, and manufacturing operations.
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