Biologics Validation Specialist

Catalent Pharma Solutions•Kansas City, MO

1d•Onsite

About The Position

The Biologics Validation Specialist serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration. Catalent’s Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions—from science and engineering to operations and logistics.

Requirements

Bachelor’s Degree in Life Sciences, Physical Science, or Engineering field
Minimum 2 years of relatable experience within a laboratory, validation, or quality environment

Nice To Haves

Prior cGMP experience highly preferred

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 events, as well as provide input to site as a SME
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 any change control activities as required
Participate in any tasks associated with system implementation or upgrades as required
Lead/support periodic and data integrity reviews
Participate, support, and drive Continuous Improvement initiatives
All other duties as assigned