Cork city, Ireland | Posted on 03/12/2026
The Computer System Validation (CSV) Engineer with MES experience is responsible for ensuring that computerised systems used in manufacturing and quality operations are validated and maintained in compliance with regulatory requirements.
The role focuses particularly on the validation and lifecycle management of Manufacturing Execution Systems (MES), ensuring systems meet GMP standards and support reliable manufacturing processes.
The CSV Engineer collaborates closely with Automation, IT, Quality Assurance, Manufacturing, and Engineering teams to deliver validation activities across system implementation, upgrades, and continuous improvement initiatives.
Key Responsibilities
Computer System Validation
Execute the full Computer System Validation lifecycle in accordance with regulatory requirements and industry best practices (e.g.,
GAMP 5
,
FDA 21 CFR Part 11
,
EU Annex 11
).
Develop and maintain validation documentation including:
Validation Plans
User Requirement Specifications (URS)
Functional Specifications (FS)
Operational Qualification (OQ)
Performance Qualification (PQ)
Traceability Matrices
Support system change controls, periodic reviews, and revalidation activities.
MES Implementation & Support
Participate in the implementation, configuration, and validation of
Manufacturing Execution Systems (MES)
such as:
Ensure MES solutions meet regulatory and operational requirements.
Support recipe configuration, electronic batch records (EBR), and system integration with other platforms (ERP, LIMS, automation systems).
Assist with MES troubleshooting and system improvements.
Compliance & Quality Assurance
Ensure all systems meet global regulatory requirements including
FDA
,
EMA
, and
GMP
guidelines.
Participate in internal and external audits related to computerised systems validation.
Maintain validation documentation in accordance with site quality systems.
Ensure data integrity principles are applied across computerised systems.
Project & Stakeholder Support
Work closely with automation engineers, IT teams, system integrators, and quality teams during project execution.
Support new system implementations, upgrades, and migrations.
Provide CSV support during system FAT, SAT, and commissioning activities.
Contribute to project planning and validation strategies for new digital manufacturing initiatives.
Maintain validation documentation and ensure version control.
Support continuous improvement initiatives for validation processes and digital systems.
Assist in the development of validation templates and standards across the organization.
Requirements
Education
Bachelor's degree in Engineering, Computer Science, Information Systems, or related technical discipline.
Experience
3–6 years of experience in Computer System Validation within the pharmaceutical, biotech, or life sciences industry.
Experience validating Manufacturing Execution Systems (MES).
Strong knowledge of GMP environments and validation standards.
Experience with electronic batch records (EBR) and digital manufacturing solutions.
Technical Skills
Manufacturing Execution Systems (MES)
Electronic Batch Records (EBR)
Risk-based validation approach
Change control and deviation management
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