Lab CSV IT Engineer

SimoTech; Cork; On-site; EUR 62,000 - 90,000; Part time

Job summary

SimoTech is seeking a Lab IT CSV Engineer to support laboratory system validation and compliance for a biopharma client in Co. Cork.

You will implement, validate, and maintain laboratory computerised systems, collaborating with Quality, Laboratory, Engineering, and IT teams to ensure GMP compliance and data integrity. The role covers SDLC artifacts, audit readiness, and IT cybersecurity alignment in a highly regulated environment, with a focus on continuous improvement and delivering

Qualifications

• 3-5 years' experience in Computer System Validation within GMP-regulated environments.
• Working knowledge of GxP systems, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Experience generating and executing validation documentation.
• Exposure to laboratory systems such as LIMS, CDS, Empower, ELN, LabX, LabVantage, or similar platforms.
• Good understanding of system lifecycle management and quality systems.
• Strong communication and stakeholder engagement skills.
• Ability to work independently while supporting larger project teams.

Responsibilities

• Support the planning, execution, and review of CSV deliverables for laboratory systems.
• Perform equipment categorisation and assist with effort estimations.
• Execute validation activities for new and existing laboratory computerised systems.
• Author, review, and maintain SDLC and validation documentation including URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports.
• Support system integrations and ensure compliance with IT and cybersecurity requirements.
• Participate in change control, deviation investigations, CAPA activities, and periodic reviews.
• Assist with audit preparation and provide support during internal and external inspections.
• Collaborate with Quality, Laboratory, Engineering, and IT teams to ensure compliance with GxP regulations.
• Communicate project progress, risks, and issues to project leads and stakeholders.

Skills

GxP knowledge

21 CFR Part 11 knowledge

Data Integrity

Validation documentation

Stakeholder engagement

Independent working

Education

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

Tools

LIMS

CDS

Empower

ELN

LabX

LabVantage

Job description

What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients' life-changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more.

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

In this role, you will contribute to the implementation, validation, and ongoing support of laboratory computerised systems, partnering with cross-functional stakeholders to ensure systems remain compliant, reliable, and fit for purpose.

You will play an active role in system lifecycle activities, support continuous improvement initiatives, and help deliver solutions that enable the development and manufacture of life-changing medicines within a highly regulated GMP environment.

This is a 12-month contract opportunity, ideally suited to candidates with a preference for an hourly-rate contract.

Key Responsibilities

• Support the planning, execution, and review of CSV deliverables for laboratory systems.
• Perform equipment categorisation and assist with effort estimations.
• Execute validation activities for new and existing laboratory computerised systems.
• Author, review, and maintain SDLC and validation documentation including URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports.
• Support system integrations and ensure compliance with IT and cybersecurity requirements.
• Participate in change control, deviation investigations, CAPA activities, and periodic reviews.
• Assist with audit preparation and provide support during internal and external inspections.
• Collaborate with Quality, Laboratory, Engineering, and IT teams to ensure compliance with GxP regulations.
• Communicate project progress, risks, and issues to project leads and stakeholders.

Key Requirements

• Bachelors degree in Engineering, Computer Science, or a related technical discipline.
• 3-5 years' experience in Computer System Validation within GMP-regulated environments.
• Working knowledge of GxP systems, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Experience generating and executing validation documentation.
• Exposure to laboratory systems such as LIMS, CDS, Empower, ELN, LabX, LabVantage, or similar platforms.
• Good understanding of system lifecycle management and quality systems.
• Strong communication and stakeholder engagement skills.
• Ability to work independently while supporting larger project teams.

What SimoTech Can Offer

• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
• Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
• Opportunity to work with large corporate clients on exciting capital projects.