Job Title: Computer System Validation (CSV) Engineer

Location: On-site (Limerick)

Role Overview:
The CSV Engineer will be responsible for ensuring that all computerised systems within the pharmaceutical environment are validated in compliance with industry regulations and company requirements. This specialist role supports the implementation, qualification, and ongoing compliance of automated systems used throughout manufacturing, laboratory, and business processes.

Key Responsibilities:

Plan, author, execute, and maintain validation protocols and documentation for new and existing computer systems (including manufacturing, laboratory, and business systems).
Ensure all CSV activities comply with relevant regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5, GMP).
Collaborate with IT, QA, Engineering, and Operations teams to identify, scope, and manage CSV projects.
Review and approve lifecycle documents, including User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, and validation summary reports.
Participate in system implementation projects, supporting system development, testing, and deployment activities.
Manage changes to validated computer systems through formal change control processes.
Conduct periodic reviews and re-validation activities as required.
Support investigations, deviations, CAPAs, and audits relating to computer systems.
Provide training and guidance to cross-functional teams on CSV requirements and practices.
Keep up to date with regulatory trends and technology changes impacting CSV.

Candidate Requirements:

Degree in Engineering, Computer Science, Life Sciences, or related discipline.
Demonstrated experience in CSV within the pharmaceutical or other regulated industries.
Strong knowledge of regulations, quality standards, and best practices for computer systems validation (GxP, GAMP 5, FDA 21 CFR Part 11, Annex 11).
Experience developing and executing validation protocols (IQ/OQ/PQ) for manufacturing, lab, or business systems.
Understanding of SDLC concepts, test methodologies, and change management in a regulated environment.
Excellent analytical, documentation, and problem-solving skills.
Effective communication and interpersonal skills; able to work independently and collaboratively.
Attention to detail and commitment to compliance and quality.

Preferred Skills:

Experience with automated manufacturing and laboratory systems, MES or LIMS.
Previous participation in regulatory audits or inspections.
Familiarity with project management tools and methodologies.

CSV Engineer

Job Description