Computer System Validation Engineer at ZEISS Group

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

Apply for Computer System Validation Engineer at ZEISS Group in Lisboa, P11, PT. This full time on site position offers great opportunities for career growth.

Your Role

As a Computer System Validation Engineer you are responsible for ensuring that all computer systems and applications used within the organization comply with regulatory requirements and industry standards. Your role involves planning, executing, and documenting validation activities to ensure that systems are fit for their intended use and operate consistently as expected.

Your Tasks

• Validation Planning
  • Develop and maintain validation plans, protocols, and reports for computer systems.
  • Define the scope and objectives of validation activities in collaboration with stakeholders.
• Risk Assessment
  • Conduct risk assessments to identify potential issues and ensure that appropriate controls are in place.
  • Develop and implement risk mitigation strategies.
• Validation Execution
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing systems.
  • Execute test scripts and document results, ensuring that all deviations are recorded and addressed.
• Documentation
  • Create and maintain comprehensive validation documentation, including validation plans, test scripts, deviation reports, and validation summary reports.
  • Ensure that all documentation meets regulatory requirements and internal standards.
• Compliance
  • Ensure that all computer systems comply with relevant regulations such as FDA 21CFR Part11, GxP, and other applicable standards.
  • Stay updated with industry best practices and regulatory changes to ensure ongoing compliance.
• Collaboration
  • Work closely with cross‑functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
  • Provide training and guidance to team members on validation processes and regulatory requirements.
• Continuous Improvement
  • Identify opportunities for process improvements and implement changes to enhance the efficiency and effectiveness of validation activities.
  • Participate in internal and external audits and provide support for regulatory inspections.

Your Profile

• Education: Degree in Engineering or Software (e.g., Computer Science, Life Sciences, Mechanical Engineering, or related field).
• 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.
• Excellent analytical and problem‑solving skills.
• Proficiency in creating and executing validation documentation.
• Strong attention to detail and organizational skills.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Expertise in national and international Medical Device standards and regulations, Regulation (EU) 2017/745, ISO13485:2016, MDSAP, MPDG, etc.
• Fluent in English; German is an advantage.

Your ZEISS Recruiting Team: Joe Taroni