Senior Computer System Validation Engineer

ZEISS Group; Lisboa; Presencial; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

ZEISS Group in Lisboa, PT, is seeking a Computer System Validation Engineer for an on‑site, full‑time role. You will plan, execute, and document validation activities to ensure systems meet regulatory requirements and function as intended.

The role involves IQ/OQ/PQ execution, risk assessments, and close collaboration with IT, QA, and operations, ensuring continuous improvement and compliance with FDA 21 CFR Part 11, GxP, and other applicable standards.

Qualificações

• Minimum 5 years of experience in computer system validation within a regulated industry, preferably in medical devices.
• Experience with validation of ERP systems, QMS software, LIMS, MES, or other enterprise‑level applications is preferred.
• Strong understanding of validation principles, methodologies, and regulatory requirements.

Responsabilidades

• Validation Planning: develop and maintain validation plans, protocols, and reports for computer systems.
• Risk Assessment: conduct risk assessments and develop mitigation strategies.
• Validation Execution: perform IQ, OQ, and PQ for new and existing systems and document results.

Conhecimentos

Analytical skills

Problem solving

Attention to detail

Communication skills

Teamwork

Formação académica

Engineering or Software degree

Ferramentas

ERP systems

QMS software

LIMS

MES

Descrição da oferta de emprego

ZEISS Group in Lisboa, PT, is seeking a Computer System Validation Engineer for an on‑site, full‑time role. You will plan, execute, and document validation activities to ensure systems meet regulatory requirements and function as intended.

The role involves IQ/OQ/PQ execution, risk assessments, and close collaboration with IT, QA, and operations, ensuring continuous improvement and compliance with FDA 21 CFR Part 11, GxP, and other applicable standards.