Senior CSV IT Engineer – Lab Systems & Compliance Lead

SimoTechnology; Cork; On-site; EUR 85,000 - 120,000; Full time

Job summary

SimoTech in Cork is seeking an experienced Senior Lab CSV IT Engineer to lead lifecycle management of laboratory computerised systems for a biopharma client. You will partner with a Project Manager to plan and deliver a global program focused on harmonization, process improvement, and compliance.

You will provide technical leadership for CSV activities, support validation and compliance initiatives, and work with cross-functional teams to keep systems validated, secure, and aligned with

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related technical discipline.
• 7+ years’ experience in Computer System Validation within regulated industries (GMP).
• Expertise in GxP, 21 CFR Part 11, data integrity principles, and industry best practices.
• Strong experience leading CSV projects and delivering compliance programs.

Responsibilities

• Lead planning, execution, and review of CSV deliverables across laboratory systems.
• Equipment categorisation and task estimation.
• Prioritisation and escalation of issues within the team.
• Managing risk and issues and communicating with client stakeholders.
• Monitoring of deliverables and communication to client stakeholders with the Project Manager.
• Provide technical direction on validation strategies and risk assessments for new and existing systems.
• Generate and approve SDLC documentation and validation protocols per regulatory expectations.
• Oversee system integration with enterprise IT infrastructure and ensure alignment with cyber security standards.
• Manage change control, deviation investigations, and ensure continuous quality system compliance.
• Act as SME for internal and external audits, ensuring audit readiness and system traceability.
• Mentor junior engineers and contribute to knowledge sharing.

Skills

CSV experience

Leadership

Stakeholder management

Regulatory compliance

GxP

SDLC documentation

Education

Bachelor’s degree in Engineering, Computer Science, or related technical discipline

Tools

Validation tools

Job description

SimoTech in Cork is seeking an experienced Senior Lab CSV IT Engineer to lead lifecycle management of laboratory computerised systems for a biopharma client. You will partner with a Project Manager to plan and deliver a global program focused on harmonization, process improvement, and compliance.

You will provide technical leadership for CSV activities, support validation and compliance initiatives, and work with cross-functional teams to keep systems validated, secure, and aligned with