Validation Analyst I
About The Position
Validation Analyst I Position Summary Shift: Monday-Friday 8am-5pm 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. This Validation Analyst I serves as a Validation representative for PCH CDS Early Phase in manufacturing and laboratory disciplines in delivering validation-qualification programs and projects, consistent with Catalent guidelines and Regulatory requirements.
Requirements
- Bachelor's Degree in Life Sciences, Engineering, or related field.
- Minimum of 2 years validation, engineering, or relatable experience.
- Strong and in-depth knowledge of Validation, Quality and Regulatory Compliance.
- Understanding of pharmaceutical solid dose commercial manufacturing and analytical laboratory testing.
- Familiarity with cGMPs, ISPE GAMP5 and fundamental validation practices of the FDA, MHRA and other similar Regulatory agencies.
Nice To Haves
- Experience working in a cGMP environment highly preferred.
Responsibilities
- Ensure Validation program deliverables are executed per established project Objectives, Timelines, Resources, Cost and Quality from small to large site-level technology program rollouts.
- Generate, execute (where applicable), approve and summarize validation protocols for GMP equipment-instrumentation qualification, commissioning and other supporting Validation program commitments per Catalent and Regulatory policies, techniques, standards and best practices.
- Work with external technology vendors, internal support groups (Site IT, Global IT, Validation, QA) and internal Business Units (Manufacturing, Pharmaceutics, Analytics, Quality Control, Facilities, Engineering) to successfully manage all assigned Validation program deliverables.
- Successful application of solid Project Management skills in procurement, integration, and implementation of new and upgrades of laboratory software, instruments, applications, and information systems.
- Participate, support, and drive Continuous Improvement initiatives.
- Assist in development, training and implementation of Validation policies and procedures.
- All other duties, as assigned.
Benefits
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
- Catalent offers rewarding opportunities to further your career!
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
