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Process Validation Engineer
3 weeks ago
Process Validation EngineerPosition Summary100% on-siteShift: Monday-Friday 8am-5pmCatalent 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 assignedThe 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.The candidate:Bachelor’s degree in a Technical or Life Sciences discipline with a minimum of two (2) years of experience in the pharmaceutical industry; orAssociate 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.Why you should join Catalent:Competitive medical benefits and 401K152 hours PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity to work on Continuous Improvement ProcessesCatalent 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 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 . 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.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .
