Computer System Validation Engineer

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

Computer System Validation Engineer ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries generating more than 11.8 billion euros in revenue with around 46,000 employees across 50 countries around the globe.

We're looking for a Computer System Validation Engineer to join our team in Lisbon, Portugal.

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.

This 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 21 CFR Part 11, 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 a related field)
• Work Experience Minimum of 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.
• Specific Knowledge/Skills 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, ISO 13485:2016, MDSAP, MPDG, etc.
• At minimum fluent in English. German is an advantage.

Your ZEISS Recruiting Team

Joe Taroni Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day - in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow. Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.