Biologics Validation Specialist

Position Summary Biologics Validation SpecialistWork Schedule: Monday – Friday 1st shift, 100% onsite. Location: Catalent’s Kansas City (KCM) facility. The role serves as a validation representative for laboratory validation activities, including equipment qualification and system administration. Responsibilities Generate, execute and summarize validation documentation for process equipment qualification. Lead Validation/Qualification/CSV efforts for equipment purchased or modified (FAT, SAT, OQ, PQ). Coordinate with Quality, technical scientists, and vendors for validation protocols, execution, and final reports. Generate, execute and summarize project plans; conduct and peer‑review change controls; review validation‑related exceptions and events; and provide input to the site as a subject‑matter expert. Contribute to the development and revision of validation concepts, techniques, and standards to ensure compliance with regulatory requirements. Assist in validation‑related issue resolutions for all GMP laboratory equipment. Generate and participate in change‑control activities as required. Participate in system implementation or upgrade tasks as required. Lead/support periodic and data integrity reviews. Participate in, support, and drive Continuous Improvement initiatives. Perform all other duties as assigned. Qualifications Bachelor’s Degree in Life Sciences, Physical Science, or Engineering field. Minimum 2 years of relatable experience within a laboratory, validation, or quality environment. Prior cGMP experience highly preferred. Benefits Day‑one benefits: medical, dental, vision, 401(k) match, tuition reimbursement, and wellness perks. Paid time off: 152 hours + 8 holidays. Inclusive culture with Employee Resource Groups and community initiatives. Discounts from 900+ merchants via Perkspot. Equal Opportunity Employer Catalent is an Equal Opportunity Employer, including disability and veterans. #J-18808-Ljbffr