One of my key clients are specialises in the purification and sterile filling of biotech products, including some of their most successful treatments for oncology and arthritis. There Cork site is a vibrant part of the local community for nearly 35 years and is now one of the region's largest employers, with a team of 500 people on site, and growing. They are currently looking for a CSV Engineer to join their existing QA IT Validation team.
The CSV Engineer will be responsible for the oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation, System Development Lifecycle, Cyber Security and Data Integrity requirements. This will include supporting implementation of new automated equipment and a DCS on a key site project
Role: CSV Engineer
Contract: 12 Month contract
Hourly Rate: DOE
- Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports.
- Providing independent quality review and approval of system changes.
- Supporting and approving computerised systems investigations and deviations.
- Ensuring consistent approach to qualification, change and deviation management across systems
- Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
- Working knowledge of relevant regulations and industry standards.
- Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
This is a great opportunity to join a truly global community in Cork
Not sure yet? No CV ready? Give me a call on 01-8883477 for more information
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales