Process Validation Engineer

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. This Process Validation Engineer provides direct validation support to pharmaceutical development and manufacturing operations.

Requirements

• Collaborate with the Cleaning Verification and Validation Analytical Group to develop draft cleaning verification and validation protocols.
• Review cleaning validation protocols, residue limits, reports, and cleaning verification/validation summary packages.
• Evaluate the impact of planned and unplanned changes to formulations, processes, or equipment on cleaning validation status.
• Author and review equipment and utilities qualification protocols and summary reports.
• Review executed qualification protocols and summary reports for completeness, accuracy, and compliance.
• Assist with the execution of equipment and utilities qualification activities as required.
• Ensure validation documentation is archived in accordance with GMP documentation retention requirements.

Benefits

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