This leading global biologics organisation provides comprehensive integrated and customisable services to the biopharmaceutical and related industry sectors from contract development services to contract manufacturing services. Recently, this business has announced expansions into regions such as the U.S and Ireland, where significant investment has been undertaken to build a new cell culture green-field manufacturing site.
Once built, this manufacturing site will be the largest single-use biologics manufacturing plant globally. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site.
To support ongoing projects, an opportunity has arisen for a Senior CSV Engineer to join the organisation on a contract basis.
- Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirements specifications, risk assessments, qualification protocols, requirements traceability matrices and validation reports.
- Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
- Perform business analysis activities.
- Ensure that computer systems and their associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
- 5 years' experience working in the Life Sciences industry.
- Experience of Chrome and AxiChrome skids validation
- Experience of PLC/Automation system validation.
- Bachelors or Master's degree in Engineering, Computer Sciences or related discipline.
Competitive hourly rate offered for an initial 12-month contract. Immediate start if possible.
For a confidential discussion contact Helena Boyle on (01) 6321870.