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Automation Validation Engineer III(10204167)

Company: OMI
Location: Vacaville
Posted on: June 26, 2020

Job Description:

Resources will be remote until shelter in place orders are lifted Responsibilities Completion of all applicable training requirements required to support project activities Work with Automation, Validation and Quality to develop Qualification Plan and Summary Support in development of design and risk assessment documents Development, approval and execution of qualification deliverables for the completion of Commissioning Qualification (CQ) activities in accordance with Genentech procedures and approved Qualification strategy Support development and execution of change records and discrepancies Manage Automation Engineering Trace Matrix (ETM) through completion and Quality approval Generation and approval of new Automation test typical, as needed Review, and revise Automation documents Skills Eight or more yearsrsquo experience in CQ of Automation systems in GMP manufacturing environments Experience with distributed control systems, software development methodologies and automated system life cycle support in a regulated industry, specifically with Honeywell Experion PKS TotalPlant Batch, and POMSnet is highly desired. Experience with DeviceNet and Allen-Bradley ControlLogix is a plus. Familiarity with Instrumentation, Systems, and Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems. Thorough understanding of cGMPrsquos particularly as they relate to the operation, validation and maintenance of computer-controlled systems. Strong proficiency in validation, commissioning and qualification principles and techniques, and demonstrated ability in successfully applying that knowledge. Effective communication and interpersonal skills with technical, operations, manufacturing, quality and engineering personnel as well as project personnel leadership. Education Skills Required ALLEN-BRADLEY CONTROL SYSTEMS DISTRIBUTED CONTROL SYSTEMS ENGINEER GMP Additional S88 SOFTWARE DEVELOPMENT TRAINING BIOCHEMISTRY CGMP LIFE SCIENCE MAINTENANCE STRUCTURED SOFTWARE INSTRUMENTATION LIFE CYCLE OPERATIONS RISK ASSESSMENT Bachelorrsquos degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validationGMP job experience.

Keywords: OMI, Vacaville , Automation Validation Engineer III(10204167), Engineering , Vacaville, California

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