Lead CSV Engineer – Lab Systems & Validation

Simotechnology; Cork; On-site; EUR 90,000 - 130,000; Full time

Job summary

SimoTech is seeking an experienced Senior Lab CSV IT Engineer to lead lifecycle management of laboratory computerised systems for our biopharma client in Co Cork, Ireland. You will partner with a dedicated 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

Qualifications

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

Responsibilities

• Lead planning, execution, and review of CSV deliverables across laboratory systems.
• 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

GxP compliance

Regulatory knowledge

Stakeholder management

Education

Bachelor's degree in Engineering/CS or related

Tools

Validation protocols

21 CFR Part 11 awareness

Job description

SimoTech is seeking an experienced Senior Lab CSV IT Engineer to lead lifecycle management of laboratory computerised systems for our biopharma client in Co Cork, Ireland. You will partner with a dedicated 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