Lab IT CSV Engineer — GMP Validation Pro (12-Month)

SimoTechnology; Cork; On-site; EUR 55,000 - 83,000; Full time

Benefits offered by this job

Educational support

Career progression

Excellent salary and benefits

Job summary

SimoTech is seeking a Lab IT CSV Engineer to support validation and compliance activities for our biopharma client in Co. Cork, Ireland.

You will implement, validate, and support laboratory computerized systems, collaborating with Quality, Laboratory, Engineering and IT teams to ensure systems remain compliant, reliable and fit for purpose. This is a 12-month contract, ideally suited to candidates who prefer an hourly-rate arrangement.

Qualifications

• Bachelor’s degree in engineering, computer science, or a related technical discipline.
• 3–5 years’ experience in computer system validation within GMP environments.
• Experience with GxP systems and 21 CFR Part 11/Annex 11.
• Experience generating and executing validation documentation.
• Exposure to laboratory systems (LIMS, CDS, Empower, ELN, LabX, LabVantage).
• Strong communication and stakeholder engagement skills.
• Ability to work independently within project teams.

Responsibilities

• Support CSV deliverables planning, execution, and review for laboratory systems.
• Perform equipment categorisation and assist with effort estimations.
• Execute validation activities for new and existing systems.
• Author and maintain SDLC and validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Traceability, Validation Reports).
• Support system integrations and ensure IT/cybersecurity compliance.
• Participate in change control, deviations, CAPA, and periodic reviews.
• Assist with audits and inspections.
• Collaborate with Quality, Lab, Engineering and IT to ensure GxP compliance.
• Communicate project progress, risks, and issues to leads.

Skills

GxP knowledge

21 CFR 11

Validation planning

Stakeholder engagement

Independent work

Education

Bachelor's degree in Engineering/Computer Science

Tools

LIMS

CDS

Empower

ELN

LabX

LabVantage

Job description

SimoTech is seeking a Lab IT CSV Engineer to support validation and compliance activities for our biopharma client in Co. Cork, Ireland.

You will implement, validate, and support laboratory computerized systems, collaborating with Quality, Laboratory, Engineering and IT teams to ensure systems remain compliant, reliable and fit for purpose. This is a 12-month contract, ideally suited to candidates who prefer an hourly-rate arrangement.