Leading biopharmaceutical CDMO are continuing to expand their Irish operation by establishing a new state-of-the-art facility in north Leinster. A vacancy has now arisen for a CSV Engineer. This site will manufacture for global supply and is expanding in response to growing customer requirements.

If you are passionate about technology, enjoy the challenge of working in a start-up environment and are ambitious this is a fantastic opportunity to join a rapidly expanding organisation.

The Role

• Author GxP Computerised System Lifecycle documents, such as VP, URS, FRA,QRA, IOQ, RTM, Test summary reports, Validation summary reports
• Execute test protocols (IOQs), generate reports and resolve no-conformance where required
• Act as a CSV reviewer on documentation such as change requests and CQV/Vendor packs
• Update CSV Document tracker and report on CSV activity/action on weekly team tracking
• Support other team members as and when required. This may from time to time involve working outside normal working hours in order to achieve defined objectives
• Communicate with cross functional teams and ensure the CSV deliverables remain on track and escalate actions when required.

The Person

• An ideal candidate would be a life sciences professional with 2-5 years' CSV experience gained in the Bio-Pharmaceutical environment. But we would also consider professionals from Pharma/Med-device industry
• Experience with PLC based manufacturing systems would be preferred.
• Knowledge of industry guidance (GAMP5)
• Minimum Bachelor's degree in a technical discipline (IT, Pharma, Bio-Pharma, Biology (Micro), Chemical, Electrical, Electronics etc)

To discover more about this opportunity, apply now or contact Emma Mullen at HRM on +353 87 7636 9263 for a confidential discussion.