Validation Analyst I

Catalent seeks a Validation Analyst I to support validation and qualification programs across manufacturing and laboratory operations at the Kansas City facility. The role involves managing validation deliverables, ensuring regulatory compliance, and collaborating across multiple teams on equipment qualification and system implementation projects.

Responsibilities

• Execute validation program deliverables according to project objectives, timelines, resources, and quality standards
• Generate, execute, approve, and summarize validation protocols for equipment qualification and commissioning
• Collaborate with technology vendors, internal support groups, and business units to manage validation deliverables
• Apply project management skills to procurement, integration, and implementation of laboratory systems and instruments
• Support continuous improvement initiatives and assist in developing validation policies and procedures

Requirements

• Bachelor's degree in Life Sciences, Engineering, or related field
• Minimum 2 years of validation, engineering, or related experience
• In-depth knowledge of validation, quality, and regulatory compliance standards
• Understanding of pharmaceutical solid dose manufacturing and analytical laboratory operations
• Familiarity with cGMP, ISPE GAMP5, and FDA/MHRA regulatory frameworks
• Strong technical writing and Microsoft Office proficiency (Word, Excel, PowerPoint, SharePoint)
• Knowledge of Six Sigma principles and Project Management Professional disciplines