Computer System Validation Engineer

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 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

You Will Have

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