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Qualification engineer, infrastructure | Engineer in Engineering Job in South Plainfield NJ | 74351

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Qualification engineer, infrastructure

Location:
South Plainfield, NJ
Description:

Specific Job Responsibilities Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5. Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages. Compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements. May also investigate and troubleshoot problems that occur and determine solutions. Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. Maintains all documentation pertaining to validation. Will assist in developing procedures and/or protocols. Coordinates contract personnel through the completion of assignments. Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required. Knowledge, Education & Experience Understanding and application of validation principles, concepts, practices, and standards.- 8+ years Working knowledge of current Good Manufacturing Practices (GMPs). Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments. 6+ years qualifying infrastructure and OT networks Working knowledge of validation of process control (PCS) and data acquisition systems is preferred. Strong verbal, written, and interpersonal communication skills. Proficient in Microsoft Office applications. For more details: https://jobs-search.org/qualification-engineer_south-plainfield-c439476/qualification-engineer-infrastructure-job-in-south-plainfield-new-jersey_i2404096425
Posted:
November 1 on Jobs-Search
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Qualification engineer, infrastructure is a Engineering Engineer Job located in South Plainfield NJ. Find other listings like Qualification engineer, infrastructure by searching Oodle for Engineering Engineer Jobs.