Process Validation Engineer II

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 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.

• Some exposure to hazardous chemicals and other active chemical ingredients

• Position requires the capacity to handle and manipulate objects using hands and arms

Why you should join Catalent

• 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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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