Lab CSV IT Engineer 1735

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

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

SimoTech is seeking a Lab IT CSVEngineer to support laboratory system validation and compliance activities forour biopharma client in Co. Cork.

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

You will play an active role insystem lifecycle activities, support continuous improvement initiatives, andhelp deliver solutions that enable the development and manufacture oflife-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 forlaboratory systems.
  
• Perform equipment categorisation and assist with effort estimations.
  
• Execute validation activities for new and existing laboratory computerisedsystems.
  
• Author, review, and maintain SDLC and validation documentation includingURS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, andValidation Reports.
  
• Support system integrations and ensure compliance with IT andcybersecurity requirements.
  
• Participate in change control, deviation investigations, CAPAactivities, and periodic reviews.
  
• Assist with audit preparation and provide support during internal andexternal inspections.
  
• Collaborate with Quality, Laboratory, Engineering, and IT teams toensure compliance with GxP regulations.
  
• Communicate project progress, risks, and issues to project leads andstakeholders.
  

Requirements

Key Requirements

• Bachelors degree in Engineering, Computer Science, or a relatedtechnical discipline.
  
• 3-5 years' experience in Computer System Validation within GMP-regulatedenvironments.
  
• Working knowledge of GxP systems, 21 CFR Part 11, Annex 11, and DataIntegrity 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

• Roleprovides a high degree of autonomy to allow the successful candidate to reachtheir full potential.
  
• Developnew skills and enhance technical ability by working with innovativetechnologies in a multi-disciplined environment.
  
• Opportunityto work with large corporate clients on exciting capital projects.