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
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
