Computer System Validation Engineer – Regulated ERP/LIMS (Lisbon)

ZEISS Group; Lisboa; Presencial; EUR 60 000 - 85 000; Tempo integral

Resumo da oferta

ZEISS in Lisbon, Portugal is seeking a Computer System Validation Engineer to ensure that computer systems and applications comply with regulatory requirements and industry standards.

Responsibilities include planning, executing, and documenting IQ/OQ/PQ activities, creating validation plans, risk assessments, deviation reports, and supporting audits. Fluent in English; German is an advantage.

Qualificações

• Minimum of 5 years in computer system validation in regulated industries.
• Experience validating ERP, QMS, LIMS, MES or enterprise apps.
• Fluency in English; German is an advantage.
• Strong knowledge of validation principles and regulatory requirements.

Responsabilidades

• Develop and maintain validation plans, protocols, and reports.
• Define the scope and objectives of validation activities with stakeholders.
• Perform IQ/OQ/PQ for new and existing systems and document results.
• Create and maintain validation documentation and deviation reports.
• Ensure compliance with FDA 21 CFR Part 11, GxP and related standards.
• Collaborate with IT, QA and Operations, and support audits.
• Identify process improvements and contribute to continuous improvement.

Conhecimentos

Validation principles

Analytical thinking

Documentation skills

Communication skills

Team collaboration

Attention to detail

Formação académica

Engineering or Software degree

Ferramentas

ERP systems

QMS software

LIMS

MES

Descrição da oferta de emprego

ZEISS in Lisbon, Portugal is seeking a Computer System Validation Engineer to ensure that computer systems and applications comply with regulatory requirements and industry standards.

Responsibilities include planning, executing, and documenting IQ/OQ/PQ activities, creating validation plans, risk assessments, deviation reports, and supporting audits. Fluent in English; German is an advantage.