Senior Lab IT CSV Engineer - Lead Validation & Compliance

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

Benefits offered by this job

Autonomy in role

Skills development opportunities

Work with large corporate clients

Job summary

SimoTech in Ireland is seeking an experienced Senior Lab IT CSV Engineer to lead lifecycle management of laboratory computerised systems for a biopharma client in Co. Cork.

You will partner with a Project Manager to plan and deliver a global laboratory systems 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 ensure systems remain

Qualifications

• 7+ years’ experience in Computer System Validation within regulated environments.
• Experience with GMP lab environments is preferred.
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles.

Responsibilities

• Lead planning, execution, and review of CSV deliverables for laboratory systems.
• Equipment categorisation and task estimation.
• Prioritisation and tasks and escalation of issues within the team.
• Managing risk and issues and effectively communicating to client stakeholders.
• Monitoring of deliverables and communication to client stakeholders alongside 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 according to regulatory expectations.
• Oversee system integration with enterprise IT infrastructure and ensure alignment with cyber security standards.
• Manage change control, deviation investigations, and ensure continuous compliance with quality systems.
• Act as SME for internal and external audits, ensuring audit readiness and system traceability.
• Mentor junior engineers and contribute to knowledge sharing within the team.

Skills

CSV leadership

Regulatory compliance

GxP knowledge

Stakeholder management

Team mentoring

SDLC documentation

Education

Bachelor’s degree in Engineering or Computer Science

Job description

SimoTech in Ireland is seeking an experienced Senior Lab IT CSV Engineer to lead lifecycle management of laboratory computerised systems for a biopharma client in Co. Cork.

You will partner with a Project Manager to plan and deliver a global laboratory systems 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 ensure systems remain