Lab IT CSV Engineer for Validation & Compliance

Simotechnology; Cork; On-site; EUR 65,000 - 80,000; Full time

Benefits offered by this job

Autonomy

Skills development

Work with corporate clients

Job summary

SimoTech in Co. Cork, Ireland, is seeking an experienced Intermediate Lab IT CSV Engineer to support validation activities for a biopharma client.

You will contribute to validation documentation and ensure compliance with quality and regulatory standards, while maintaining validated system environments. Collaborating with QA, IT and business users, you will help plan and deliver CSV deliverables, manage risk-based validation, and support system upgrades and change controls in a fast-paced,

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
• 3-5 years' experience in Computer System Validation within a regulated pharmaceutical, biotechnology, or laboratory environment.
• Working knowledge of GxP, 21 CFR Part 11, Data Integrity principles, and validation best practices.
• Experience supporting validation activities for laboratory computerised systems and SDLC documentation.
• Familiarity with system upgrades, change control processes, and risk-based validation approaches.
• Understanding of laboratory system integrations and interactions with enterprise IT infrastructure.
• Proficiency with Microsoft Office applications and general software configuration and troubleshooting.
• Strong communication and stakeholder engagement skills.

Responsibilities

• Support the execution of CSV deliverables for laboratory computerised systems throughout their lifecycle.
• Assist with equipment categorisation, risk assessments, and validation planning activities.
• Generate, review, and execute validation documentation, including protocols and reports, in accordance with regulatory and site requirements.
• Support the implementation and validation of system upgrades, enhancements, and change controls.
• Assist with the integration of laboratory systems into the wider IT infrastructure while maintaining compliance standards.
• Participate in deviation investigations and help ensure issues are documented and resolved appropriately.
• Collaborate with QA, IT, business users, and vendors to deliver project milestones and maintain validated system states.
• Support audit readiness activities by maintaining accurate validation and traceability documentation.
• Troubleshoot system and validation-related issues and contribute to continuous improvement initiatives.
• Adhere to EHS and Quality requirements and actively contribute to team objectives.

Skills

Strong communication

Stakeholder engagement

Microsoft Office

Troubleshooting

Education

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

Tools

LIMS (laboratory information management systems)

Job description

SimoTech in Co. Cork, Ireland, is seeking an experienced Intermediate Lab IT CSV Engineer to support validation activities for a biopharma client.

You will contribute to validation documentation and ensure compliance with quality and regulatory standards, while maintaining validated system environments. Collaborating with QA, IT and business users, you will help plan and deliver CSV deliverables, manage risk-based validation, and support system upgrades and change controls in a fast-paced,