Validation Analyst I

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a Validation Analyst I to join our team. In this role, you will support validation and qualification programs across manufacturing and laboratory disciplines. You will ensure compliance with Catalent guidelines and regulatory requirements while managing validation deliverables. This position offers the chance to work on diverse projects and collaborate with multiple teams to achieve successful outcomes.

Shift: Mon to Fri 8am-5pm
Location: Kansas City, MO
100% Onsite

The Role

• Ensure validation program deliverables are executed according to project objectives, timelines, resources, cost, and quality for site-level technology rollouts.
• Generate, execute (where applicable), approve, and summarize validation protocols for Good Manufacturing Practice equipment and instrumentation qualification, commissioning, and other validation commitments per Catalent and regulatory standards.
• Collaborate with external technology vendors, internal support groups (Site IT, Global IT, Validation, Quality Assurance) and internal business units (Manufacturing, Pharmaceutics, Analytics, Quality Control, Facilities, Engineering) to manage assigned validation deliverables.
• Apply project management skills in procurement, integration, and implementation of new and upgraded laboratory software, instruments, applications, and information systems.
• Participate in and support continuous improvement initiatives.
• Assist in developing, training, and implementing validation policies and procedures.
• Perform other duties as assigned.
  

The Candidate

Minimum Requirements

• Bachelor's Degree in Life Sciences, Engineering, or related field.
• Minimum of 2 years of validation, engineering, or related 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 current Good Manufacturing Practices, ISPE GAMP5, and validation practices of the FDA, MHRA, and similar regulatory agencies.
• Clear verbal and written communication skills.
• Excellent organizational skills and ability to multi-task with strong analytical problem-solving skills.
• Strong technical writing skills with proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and SharePoint.
• Understanding and application of regulatory compliance, vendor/client/regulatory audits, standard operating procedure development, change management, deviations, and quality system disciplines.
• Ability to work effectively as part of a team and contribute to team commitments.
• Understanding and application of Six Sigma principles and Project Management Professional disciplines.

Preferred Skills & Background

• Experience working in a current Good Manufacturing Practice environment highly preferred.

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback process.
• Diverse and inclusive culture.
• Opportunities for career growth within an organization dedicated to improving and saving lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement program.

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 [email protected]. 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.

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