New Senior CSV Engineering Contract available with a leading global biologic organisation that provide comprehensive, integrated and customisable services to the biopharmaceutical and related industry sectors. These services include contract development and contract manufacturing across their network in Asia, Europe and the US.
Once built, this Leinster based manufacturing site will be the largest single-use biologics plant globally and has been designed to run next generation manufacturing technology, continuous bioprocessing.
This role is focused on supporting ongoing commissioning projects for an initial 12-month contract but there is approximately 2 years work available.
- 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.
- Educated to Degree level in Engineering, Computer Sciences or related discipline.
- At least 5 years' experience working in the Life Sciences industry.
- Experience of Chrome and AxiChrome skids extremely beneficial.
- Experience in PLC/Automation systems validation required.
Competitive hourly rate offered for an initial 12-month contract.
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.