ProcessValidationEngineerII

**Process Validation Engineer II** **Position Summary** * **100% on-site** * **Shift:** Monday-Friday 8am-5pm Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. This **Process Validation Engineer II** provides direct validation support to pharmaceutical development and manufacturing operations. Under minimum supervision, this role performs quality functions to ensure accurate execution and documentation of all activities and projects as assigned **The Role** * 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. * Other duties assigned. **The Candidate** * Bachelor’s degree in a Technical or Life Sciences discipline with two years of experience in the pharmaceutical industry; or Associate degree in a Technical or Life Sciences discipline with four years of experience in the pharmaceutical industry required. * One year of validation experience required; oral solid dosage (OSD) experience pref