Process Validation Engineer

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• 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 turnkey 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.

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.

• 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.

• 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.

• 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! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is an Equal Opportunity Employer, including disability and veterans.

• Entry level

• Full‑time

• Quality Assurance

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