Validation Analyst I

Validation Analyst I will serve 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. This role ensures validation program deliverables are executed per established project Objectives, Timelines, Resources, Cost and Quality, and participates in Continuous Improvement initiatives.

Requirements

• 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.

Benefits

• Competitive medical benefits
• 401K
• 152 hours PTO
• 8 Paid Holidays