Validation Analyst I

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Career growth

Diversity & inclusion

Paid time off

Tuition reimbursement

Benefits from day one

Job summary

Catalent’s Kansas City facility is seeking a Validation Analyst I to join our team. You will support validation and qualification programs across manufacturing and laboratory disciplines, ensuring compliance with Catalent guidelines and regulatory requirements while managing validation deliverables onsite in Kansas City, MO.

The role requires a Bachelor's degree and at least 2 years of validation or related experience; strong writing and communication skills, and familiarity with GMP, ISPE

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Minimum of 2 years of validation, engineering, or related experience.
• Strong knowledge of validation, quality, and regulatory compliance.
• Understanding of GMP, ISPE GAMP5, and FDA/MHRA-like regulations.
• Clear verbal and written communication; strong analytical skills.

Responsibilities

• Execute and summarize validation protocols for equipment and instrumentation qualification.
• Collaborate with Site IT, Global IT, QA, and Manufacturing to manage deliverables.
• Apply project management in procurement, integration, and implementation of software and instruments.
• Participate in continuous improvement and validation policy development.

Skills

Project management

Regulatory compliance

Technical writing

MS Office

Six Sigma

PMP

Education

Bachelor's Degree in Life Sciences/Engineering

Tools

Word

Excel

PowerPoint

SharePoint

Job description

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.

Equal Opportunity Employer

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

Accommodation and Disability

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 [e-mail]. 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.

Company Overview

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.