Senior CSV Engineer – GMP Validation & Data Integrity

SimoTechnology; Cork; Ibrido; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

SimoTech in Co. Cork, Ireland seeks an experienced CSV Engineer to validate GMP computerised systems and equipment. The role focuses on lifecycle validation, IQ/OQ/PQ execution, change control, data integrity, and regulatory readiness, with a hybrid work setup requiring at least 3 days onsite weekly.

You will collaborate with automation, IT, QA and operations to ensure compliant system integration, prepare documentation, and support audits and inspections for a leading biopharma client.

Competenze

• Bachelor-level degree in engineering, computer science or life sciences.
• Minimum 5 years’ experience in Life Sciences CSV roles.
• Technical experience with MES, PLC, SCADA or related automation systems is advantageous.
• Proven CSV lifecycle experience for GMP computerised systems and equipment.
• Strong knowledge of GAMP 5, data integrity, and 21 CFR Part 11/Annex 11 compliance.
• Experience executing IQ/OQ/PQ/UAT and preparing supporting documentation.
• Involvement with change control, deviation and CAPA management processes.
• Experience with periodic evaluations to maintain a validated state.
• Excellent attention to detail and cross-functional collaboration across tech and QA.

Mansioni

• Perform full lifecycle CSV for GMP systems, from planning to IQ/OQ/PQ execution and reporting.
• Develop and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Reports, and Traceability Matrices.
• Conduct and support User Acceptance Testing (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 CAPA management processes.
• Collaborate with automation, IT, QA, and operations to ensure compliant system integration.
• Maintain awareness of data integrity and adhere to GAMP 5 and regulatory standards.
• Participate in regulatory inspections and support validation evidence readiness.

Conoscenze

CSV lifecycle

IQ/OQ/PQ

UAT

Data integrity

GAMP 5

Regulatory compliance

CAPA management

Audit readiness

Cross-functional collaboration

Formazione

Bachelor’s Degree in Engineering/Computer Science/Life Sciences

Strumenti

MES

PLC

SCADA

Descrizione del lavoro

SimoTech in Co. Cork, Ireland seeks an experienced CSV Engineer to validate GMP computerised systems and equipment. The role focuses on lifecycle validation, IQ/OQ/PQ execution, change control, data integrity, and regulatory readiness, with a hybrid work setup requiring at least 3 days onsite weekly.

You will collaborate with automation, IT, QA and operations to ensure compliant system integration, prepare documentation, and support audits and inspections for a leading biopharma client.