CSV Engineer: GMP Validation Expert (Hybrid)

SimoTech; Cork; Hybrid; EUR 70,000 - 95,000; Full time

Job summary

SimoTech in Cork, Ireland, seeks an experienced CSV Engineer to validate GMP computerised systems for a life sciences client. The role combines hands-on lifecycle validation (IQ/OQ/PQ) with change control and data integrity activities in a regulated environment.

You will collaborate with automation, IT, QA and operations to ensure systems are compliant, documented, and maintained, with a hybrid onsite requirement of at least three days per week.

Qualifications

• Bachelor’s Degree in Engineering, Computer Science, or Life Sciences is required.
• Minimum of 5 years’ experience in Life Sciences CSV roles.
• Experience with MES/PLC/SCADA is advantageous.
• Strong knowledge of GAMP 5, data integrity, and 21 CFR Part 11 compliance.
• Experience executing IQ/OQ/PQ/UAT and preparing supporting documentation.
• Involvement in change control, deviation and CAPA processes is expected.
• Experience supporting audit readiness and responses to validation queries.
• Able to collaborate across QA, automation, IT and operations.

Responsibilities

• Perform full lifecycle CSV for GMP systems and equipment from planning through IQ/OQ/PQ and reporting.
• Develop and maintain validation documentation including Validation Plans and Traceability Matrices.
• Conduct and support UAT, ensuring system functionality meets business and compliance needs.
• Execute and document Periodic Reviews to maintain validated state.
• Support and review change controls, deviations, and CAPAs for data integrity.
• Collaborate with automation, IT, QA and operations to ensure compliant integration.
• Maintain awareness of data integrity principles and regulatory standards.
• Assist in regulatory inspections and validation evidence readiness.

Skills

CSV lifecycle

GAMP 5

IQ/OQ/PQ

UAT testing

Data integrity

Regulatory compliance

Documentation

Education

Bachelor’s Degree in Engineering, Computer Science, or Life Sciences

Tools

MES

PLC

SCADA

OT/IT systems

Job description

SimoTech in Cork, Ireland, seeks an experienced CSV Engineer to validate GMP computerised systems for a life sciences client. The role combines hands-on lifecycle validation (IQ/OQ/PQ) with change control and data integrity activities in a regulated environment.

You will collaborate with automation, IT, QA and operations to ensure systems are compliant, documented, and maintained, with a hybrid onsite requirement of at least three days per week.