Validation Engineer Specialist
Perrigo - Bronx, NY

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The Validation Specialist will be responsible for: Coordination of Cleaning Validations and swab support: The incumbent will attend meetings to coordinate the timing of the projects. The incumbent will, as necessary, review the current procedures with Operations and Technical Operations, and discuss any changes that need/should be incorporated prior to validation. In addition, this position will be required to write protocols, reports and other associated documents of the validation study. The incumbent will coordinate with Scheduling, Operations, Technical Operations, Analytical R&D and QC Microbiology the timing of the validation batches. Once the required number of passing batches has been met, the incumbent creates and circulates the CV report. If a CV study fails the validation, the incumbent is responsible for coordinating an investigation to determine the root cause of the failure and all necessary corrective action. The incumbent will also provide routine swab support.

Required Skills

Bachelor degree in Engineering, Chemistry, Pharmacy or a closely allied field, combined with 1 year of pharmaceutical industry experience required. Strong analytical skills are essential. Experience in the interpretation and application of FDA requirements and cGMP are necessary. The incumbent must have demonstrated the ability to organize multiple tasks and changing priorities to meet project deadlines. Excellent oral and written communication skills and excellent interpersonal skills are essential. Basic understanding of statistics preferred. Computer literacy is required.

Required Experience

Perrigo - 24 months ago - save job - block
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About this company
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From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading...