Job Details

  • Title: Automation Engineer
  • Code: RCI-9927137
  • Location: Vacaville California (CA) 95688
  • Posted Date: 03/13/2020
  • Duration: 5 Months
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  Job Description

Job Responsibilities:


Provide Commissioning and Qualification (C&Q) support to Vacaville Manufacturing Operations for CCP2 Automation, focused on the Gant Tech Tranfer project.

 

Responsibilities include:

  • Completion of all applicable training requirements required to support project activities

  • Support development and approval of Qualification Summary Report for the project

  • 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

  • Manage Automation Engineering Trace Matrix (ETM) through completion and Quality approval

  • Generation and approval of new Automation test typicals, as needed

  • Train additional team members to execute protocols, if needed

    • Update test typical testing instructions for clarification

    • Develop training guide to support execution of AIQ/AOQ.

Skills:
  • Solid understanding of regulatory compliance, good manufacturing practices and validation principles, and the ability to apply that knowledge.

  • 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.

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

  • Twelve or more years experience in C&Q of Automation systems in GMP manufacturing environments