Working hours:
39 hours per week
Onsite requirements:
Fully onsite
Engagement Type:
Contract via Ltd company
Day Rate / Hourly rate:
€75 per hour
Legal Right to Work:
Applicants must have the legal right to work in Ireland.
Sponsorship is not available for this role.
Atrium Global is supporting a client within the pharmaceutical manufacturing industry in the search for an experienced CSV Engineer to support validation and compliance activities across laboratory, production, and enterprise computerised 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.
You will work closely with IT, Quality, and Operations teams to deliver robust validation activities across laboratory instruments, manufacturing equipment, and enterprise platforms in a highly regulated GMP environment.
Responsibilities
Develop and execute validation protocols including IQ, OQ, and PQ for computer systems and software applications
Collaborate with cross functional stakeholders to ensure regulatory and internal compliance
Perform risk assessments and impact analyses to identify critical system functionalities
Create and maintain validation documentation including plans, scripts, traceability matrices, and summary reports
Conduct periodic reviews to maintain ongoing compliance
Support change control processes and assess the validation impact of system changes
Provide CSV guidance and best practice support to project teams
Work with vendors and third parties to ensure validated and compliant solutions
Support audits and regulatory inspections with appropriate documentation
Qualification of laboratory analytical instruments such as cell viability analysers and liquid handlers
Qualification of analytical instruments within production environments
Requirements
Bachelor's degree in Computer Science, Engineering, or related discipline
Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
5+ years' experience in computer system validation within a regulated pharmaceutical or biotechnology environment
Experience with risk based validation methodologies
Proven experience creating and executing validation protocols and documentation
Knowledge of SDLC and change control processes
Strong understanding of data integrity principles
Experience validating analytical instruments in QC laboratories and manufacturing environments
Experience with server and database based laboratory software and enterprise systems such as LIMS, Empower, and NuGenesis
Experience completing ERES assessments and Data Integrity Risk Assessments
Familiarity with paperless validation and testing tools such as ValGenesis, Kneat, or ALM
Strong communication, organisation, and stakeholder management skills
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