Biologics Validation Specialist

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

The Candidate:

• 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

Why you should join Catalent:

• 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

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.