New Senior CSV engineering contract available with a leading global biologic organisation who provide comprehensive integrated and customisable services to the biopharmaceutical sector. These services include contract development and contract manufacturing across their network in Asia, Europe and the US.
This role is focused on supporting ongoing commissioning projects for an initial 12-month contract but there are a number of npi projects that will see further opportunity arise.
This position is a key player within the site CSV/CQV project team, and will be responsible for a number of important tasks including:
- Completing lab-validation activities including analytical systems qualification.
- Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirement 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.
- Draft test cases for QC laboratory computerized system.
- Be responsible for establishing and revising of VP for QC laboratory computerized system.
- Lead risk assessment before test execution, such risk assessment includes but not limited to ERES assessment, system functional risk assessment.
- Responsible for review of the vendor validation documents, such as validation protocols and validation summary reports.
- Participate in deviation investigation, analysis and change assessment.
- Educated to degree level in Engineering, Computer Sciences or related discipline.
- At least 4 years' experience working in the Life Sciences industry.
- You will be familiar with upstream (ATF/Bioreactor) and downstream (AKTA, AxiChrome, DF/VF).
- Having experience in EMS/PI system validation is a plus.
- Experience of PLC/Delta V/ Automation systems validation.
- Excellent communication and technical writing skills with the ability to work with diverse multidisciplined groups.
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.