Validation Analyst I

• 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.

The role:

• 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.
  
  
  

• Bachelor's Degree in Life Sciences, Engineering, or related field.
• Minimum of 2 years validation, engineering, or relatable experience.
• Experience working in a cGMP environment highly preferred.
• 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.
  
  
  

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes
  
  
  

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.