Computer Systems Validation Engineer (CSV Validation)

Location: Dundalk, Louth
Salary: Negotiable
Posted: over 1 year ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice, Engineering Leaders and Specialists
Contact name: Helena Boyle
Contact email: helena.boyle@hrmrecruit.com

Job description

This leading global Biologics organisation are a CMO with a great product pipeline. Their expansion into Ireland will result in the recruitment of approximately 700 construction staff during the build phase, with circa 400 permanent WuXi employees to be hired over the next 3 years for the facility. Once operational, the site will be responsible for the contract manufacturing of large molecules, specifically, cell culture derived product for client organisations. There are 2 products already in pipeline for the site in 2021 when it is expected to be fully operational and FDA approved.

The company are investing €325 million in a state-of-the-art greenfield manufacturing plant which will deploy multiple single-use bioreactors for commercial bio-manufacturing. The site has been designed to run continuous bioprocessing, a next generation manufacturing technology, which will be implemented for the first time on this campus. They are the first Chinese biologics organisation to expand into the EU and in developing this site are creating the largest single use biologics facility in the world. The site will ultimately have 12 4000-litre single use bioreactors along with 6 1000-litre perfusion reactors.

The Role

This role reports to the Process Engineering and Validation Lead on site and some responsibilities include:

  • Support the process control system qualification - from design through to operational use.
  • During the project phase, be responsible for control system tracking and managing the schedule from design through to system release to operations.
  • Oversee the compliant execution and reporting of all CSV activities for process and support systems.
  • Participate on project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
  • Responsible for initiation and completion of deviations, CAPAs, and change controls for process control systems including investigations relating to equipment or process performance.
  • Support all hardware and software updates and revisions.
  • Ensure that new process systems are included in the plant maintenance and calibration program.

The Person

The ideal candidate will have the following background:

  • Eng or B.Sc in Chemical Engineering / Computer Science or other relevant qualification.
  • A minimum of 5 years' experience working in a Biologics or similar GMP environment as part of an engineering, technical services or automation / IT function.
  • Knowledge and experience with facility start-up projects (brown field or green field).
  • Experienced in the execution of commissioning and qualification of process control systems (e.g. Delta V), PLC and SCADA systems and Enterprise systems.
  • Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations in a biologics processing environment.

To learn more about this role apply online or call Helena Boyle at HRM on + 353 1 6321870 or 0873360953 for a confidential discussion.


Helena Boyle

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