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Automation Validation Engineer III
Ref No.: 20-02393
Location: Vacaville, California
Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

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 *** 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

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 Client 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 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.

Bachelor’s degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job experience.