Senior Lab CSV Engineer - Validation and Compliance Lead

SimoTech; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

SimoTech is seeking an experienced Senior Lab CSV IT Engineer to lead lifecycle management of laboratory computerised systems for a biopharma client in Co. Cork. You will partner with a Project Manager to harmonize processes, improve validation, and ensure regulatory compliance across global programs.

You will provide technical leadership for validation strategies, manage SDLC documentation, and engage audits while mentoring junior engineers and ensuring cyber security alignment.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline.
• 7+ years’ experience in Computer System Validation within regulated industries, preferably GMP laboratory environments.
• Expertise in GxP systems, 21 CFR Part 11, data integrity principles, and industry best practices.
• Strong experience leading CSV projects and delivering compliance programs.
• In-depth knowledge of lab system integrations and validation of high-impact platforms.
• Excellent leadership, influencing, and stakeholder management skills, with ability to mentor and guide teams.

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 communicating with client stakeholders.

Skills

CSV leadership

Regulatory compliance

GxP knowledge

Stakeholder management

Mentoring

Education

Bachelor’s degree in Engineering/CS or related

Job description

SimoTech is seeking an experienced Senior Lab CSV IT Engineer to lead lifecycle management of laboratory computerised systems for a biopharma client in Co. Cork. You will partner with a Project Manager to harmonize processes, improve validation, and ensure regulatory compliance across global programs.

You will provide technical leadership for validation strategies, manage SDLC documentation, and engage audits while mentoring junior engineers and ensuring cyber security alignment.