Biologics Validation Specialist
About The Position
Biologics Validation Specialist Position Summary: Work Schedule: Monday – Friday 1st shift 100% onsite 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. The Biologics Validation Specialist serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration. The Role: 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
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
- 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
Benefits
- Career growth with a clear path and regular performance reviews
- 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
- A mission-driven workplace where your work helps save lives
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
