Process Validation Engineer
About The Position
Process Validation Engineer Position Summary 100% on-site Shift: Monday-Friday 8am-5pm 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. 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. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 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
Requirements
- Bachelor’s degree in a Technical or Life Sciences discipline with a minimum of two (2) years of experience in the pharmaceutical industry; or Associate degree in a Technical or Life Sciences discipline with a minimum of four (4) years of experience in the pharmaceutical industry.
- Minimum of one (1) year of validation experience required; oral solid dosage (OSD) experience preferred.
- 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.
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.
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
Number of Employees
5,001-10,000 employees
