Validation Engineer III

Position Summary

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.

The Validation Engineer III will provide direct validation support to pharmaceutical development and manufacturing operations. Under little to no supervision the Validation Engineer III will perform quality functions to ensure accurate execution and documentation of all activities and projects as assigned.

The Role

• Collaborate with the Cleaning Verification/Validation Analytical Group to develop a draft cleaning verification/validation protocol.

• Review protocols, residue limits, reports and cleaning verification/validation summary packages.

• Evaluate impact on cleaning validation of planned or unplanned changes to formulation, process or equipment.

• Author/Review equipment qualification protocols and summary reports.

• Performvalidationtestingandanalyzedataforvalidationdocumentationtodetermineacceptability,identify deviations and make appropriate notification.

• Follow the site master validation program.

• Follow and enforce the validation life cycle approach for site.

• Proficient knowledge of Validation Principles, Validation Sampling, and OSD Manufacturing Processes/Equipment/Facilities.

• Review and approve technical documents of peers independently (protocols/reports/SOPs, risk assessments, etc.).

• All other duties as assigned.

The Candidate

• Bachelor’s degree in a Technical or Life Sciences discipline with at least 5 years of experience in pharmaceutical industry OR

• Associate degree in a Technical or Life Sciences discipline with at least 7 years of experience in pharmaceutical industry.

• At least 3 years validation experience.

• 2 years recent experience in one or more of the following areas: process validation, equipment validation, CFR 210 Part 11 software validation or cleaning validation with at least one-year experience preparing and implementing process validation protocols and authoring validation summary reports.

• 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 Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays

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 (https://careers.catalent.com/us/en) 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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