Computer System Validation Engineer - IQ/OQ/PQ Expert

Carl Zeiss Vision Portugal S.A.; Lisboa; Presencial; EUR 50 000 - 70 000; Tempo integral

Resumo da oferta

ZEISS Portugal in Lisbon seeks a seasoned Computer System Validation Engineer to ensure regulatory compliance of computer systems and applications used across the organization.

The role covers planning, executing, and documenting IQ/OQ/PQ activities, maintaining validation plans and risk assessments, and collaborating with IT, QA, and operations to drive continuous improvement and compliance with FDA 21 CFR Part 11, ISO 13485 and related standards.

Qualificações

• Strong understanding of validation principles, methodologies and regulatory requirements.
• Experience planning, executing and documenting computer system validation activities.
• Familiarity with FDA 21 CFR Part 11, ISO 13485 and related standards.

Responsabilidades

• Develop and maintain validation plans, protocols and reports for computer systems.
• Conduct IQ/OQ/PQ for new and existing systems and document results.
• Perform risk assessments and implement mitigation strategies.
• Create and maintain validation documentation meeting regulatory requirements.
• Collaborate with IT, QA and Operations to ensure successful validation.

Conhecimentos

Validation principles

Regulatory knowledge

Analytical skills

Documentation excellence

Communication

Formação académica

Engineering or Software degree

Ferramentas

ERP systems

QMS software

LIMS

MES

Descrição da oferta de emprego

ZEISS Portugal in Lisbon seeks a seasoned Computer System Validation Engineer to ensure regulatory compliance of computer systems and applications used across the organization.

The role covers planning, executing, and documenting IQ/OQ/PQ activities, maintaining validation plans and risk assessments, and collaborating with IT, QA, and operations to drive continuous improvement and compliance with FDA 21 CFR Part 11, ISO 13485 and related standards.