Process Validation Engineer II
About The Position
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.
Requirements
- 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.
- Experience in a Catalent production role with a demonstrated solid understanding of internal manufacturing processes may be considered in lieu of direct validation experience.
- Some exposure to hazardous chemicals and other active chemical ingredients.
- Position requires the capacity to handle and manipulate objects using hands and arms.
Nice To Haves
- Oral solid dosage (OSD) experience preferred.
- Process validation experience strongly preferred.
Responsibilities
- 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.
Benefits
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
