Validation Analyst I

Catalent•Kansas City, MO

8d•Onsite

About The Position

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.

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.

Nice To Haves

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

Responsibilities

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.