Senior Computer Systems Validation Engineer

Our client, a highly successful global pharmaceutical company with multiple sites nationwide are recruiting for a Senior Computer Systems Validation Engineer to join their Projects Team on a contract basis.

The Role

• You will be capable of acting as the CSV SME for the project team and providing a standardised CSV approach across capital project.
• Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan.
• You will ensure that computer systems and their associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
• Work closely with the QA-IT function and ensure their requirements are met in all deliverables.
• Approval of all AIT SDLC deliverables, ensuring compliance with standards.
• Provide FAT oversight and perform leveraging assessments.
• Work closely with suppliers/integrators to ensure compliance with MSD standards as well as liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

The Person:

• Minimum of 5 years' experience in a similar role in life sciences, ideally in Pharmaceutical manufacturing.
• Expert knowledge of GAMP5.
• Strong experience in one or all the following systems: DCS (DeltaV), PLC/SCADA systems, MES, OSI PI, Automated Utility Systems, Lab Systems, Building Automation Systems.
• Relevant Computer Science or Engineering degree or equivalent.
• Previous experience in API Manufacturing and/or Oral Solid Dose will be advantageous.
• Previous experience in high containment manufacturing (OEB4/OEB5) will be advantageous.
• Previous experience working with paperless validation systems will be advantageous.

Competitive hourly rate offered for an initial 12-month contract. Immediate start if possible.

To learn more, apply online or contact Ellen Walsh on +353 1 6321882 for a confidential discussion.