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Validation Engineer III, Equipment & CSV - Greenville North Carolina
Company: Disability Solutions Location: Greenville, North Carolina
Posted On: 04/18/2024
Validation Engineer III, Equipment & CSVCatalent'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.The PositionThe Validation Engineer III, Equipment & CSV will provide direct validation support to pharmaceutical development and manufacturing operations. Under little to no supervision the Validation Engineer III, Equipment & CSV will perform quality functions to ensure accurate execution and documentation of all activities and projects as assigned. The Role - Author/Review executed equipment qualification protocols and summary reports.
- Approve technical engineering and facility documents.
- Author/Review process validation protocols and validation summary reports.
- Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification.
- Oversight and administration of site master validation program.
- Update and maintain site validation master plan to align with company and industry regulations.
- Lead validation projects in various disciplines, develop strategy and timelines to deliver according to department and site objective and goals.-- Work with project teams to meet project milestones and deliverables to achieve OTD and RFT metrics.
- Assist in the implementation for improved site validation activities and the quality systems related to these activities.
- All other duties as assigned.The Candidate
- Bachelor's degree in a Technical or Life Sciences discipline with at least 10 years of experience in the pharmaceutical industry and at least 6 years in validation.
- Associate degree in a Technical or Life Sciences discipline with at least 12 years of experience in the pharmaceutical industry and at least 8 years in validation.
- In lieu of Technical/Life Sciences degree, a Bachelor's degree with at least 8 years of experience in the pharmaceutical industry and at least 4 years in the areas of Equipment/Facilities and Computer Validation may be substituted.
- 4 years of recent experience in one or more of the following areas: process validation, equipment validation, CFR 210 Part 11 software validation or cleaning validation - At least 3 years of experience preparing and implementing validation protocols and authoring validation summary reports.
- This position requires you to wear a respirator for your safety, and as such, employment is contingent upon you being able to complete a medical evaluation with satisfactory results prior to the start of your employment.
- 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--
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