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CSV engineer

Posted on Aug 25, 2020 by Real Staffing Group

Dublin, Ireland
Research
Immediate Start
Annual Salary
Contract/Project


12 month hourly rate contract


Very likely to extend


Dublin


1 day home working


As the CSV engineer for this leading Pharmaceuticals company, you will be responsible for leading the implementation and operation of all automation capabilities at the new Dublin facility. The CSV engineer must ensure that all automation activities are aligned with current engineering standards and are executed to schedule and in accordance with company and statutory requirements. The CSV engineer is responsible for ensuring all automation systems are validated and their validated status is maintained throughout the life cycle of the system.


Duties for this role include:



  • Performing the role of SME for computerised/automation systems.

  • Owning and maintaining the site computerised system inventory.

  • Classifying and assessing computerised systems that support manufacturing activities

  • Validating site automation systems and automation components of equipment that support manufacturing

  • Managing automation-related change controls.

  • Acting as liaison between corporate IT and site automation.

  • Overseeing the validation of global computerised systems utilised on site.

  • Ownership of SOPs and automation maintenance routines.

  • Planning and executing planned maintenance activities for automation systems.

  • Maintaining of the validated state of site automation systems through the execution of periodic reviews, security and access reviews and automation system administration activities.

  • Maintaining the system risk assessments, classifications and data integrity.


Requirements:


To be considered for this role, you should have at least 6 years of experience in Pharmaceuticals, be familiar with GAMP5 regulations, have experience working with data integrity, and automation.


If you are interested in this role, and would like to learn more, please respond to this advert, and I will call you to discuss in more detail.


Please note, you must be currently based in Ireland with a valid EU passport, or stamp 4 visa


Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales




Reference: 935154685

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