Automation Engineer III #: 21-00457

Company: HireTalent Executive Search, Temporary Staffing, R
Location: Vacaville
Posted on: February 25, 2021

Job Description:

Job DescriptionJob Title: Automation Engineer IIILocation: Vacaville, CADuration: 6 MonthsPurposeProvide Commissioning and Qualification (C&Q) Support to Vacaville Manufacturing Operations for project delivery and operational support, focused on CCP1 & CCP2 Automation and Infrastructure projects.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 (C&Q) activities in accordance with Client 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 documentsRequirements* Bachelor's degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job experience.* Eight or more years' experience in C&Q 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 DeltaV, Client Experion PKS TotalPlant Batch, and/or 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 cGMP's 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.

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