CSV Engineer (Computer System Validation Engineer)
Duration:
12 Months
Location:
Cruiserath, Dublin
Working hours:
Standard business hours
Onsite requirements:
Onsite
Engagement Type:
PAYE or LTD Company Contractor
Day Rate:
€478.26 per day
Legal Right to Work:
Candidates must have the legal right to work in Ireland. No sponsorship is available for this role.
Atrium Global is supporting a client of ours within the biologics and pharmaceutical manufacturing sector in the search for an experienced CSV Engineer to support validation activities across critical laboratory and analytical systems.
Job Overview
The CSV Engineer will be responsible for validating and maintaining computerised systems to ensure compliance with regulatory requirements and industry best practice. This role will focus on laboratory analytical instruments and associated systems, ensuring data integrity and ongoing operational compliance.
RESPONSIBILITIES
* Develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for laboratory analytical instruments such as cell viability analysers
* Create and execute test protocols to verify system compliance with data integrity principles and regulatory requirements
* Collaborate with IT, Quality Assurance and Operations teams to ensure adherence to regulatory guidelines and internal policies
* Perform risk assessments and impact analyses to identify critical functionalities and potential vulnerabilities
* Produce and maintain validation documentation including validation plans, test scripts, traceability matrices and summary reports
* Conduct periodic reviews to maintain ongoing compliance with regulatory requirements and procedures
REQUIREMENTS
* Bachelor's degree in Engineering, Science, Computer Science or a related discipline
* Experience within a large biologics or pharmaceutical organisation, ideally in Validation, Analytical or Quality Assurance functions
* Strong knowledge of computer system validation principles and processes
* Understanding of data integrity and regulatory frameworks including ALCOA+, 21 CFR Part 11 and EU Annex 11
* Experience validating laboratory or analytical instrumentation