Process Validation Engineer
About The Position
Process Validation Engineer 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 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.
Requirements
- Bachelor’s degree in a Technical or Life Sciences discipline with 2+ years of experience in the pharmaceutical industry; or Associate degree in a Technical or Life Sciences discipline with 4+ years of experience in the pharmaceutical industry required.
- 1+ year of validation experience required; oral solid dosage (OSD) experience preferred.
- 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
- Process validation experience strongly preferred.
- Experience in a Catalent production role with a demonstrated solid understanding of internal manufacturing processes may be considered in lieu of direct validation experience.
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
- Catalent offers rewarding opportunities to further your career!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
