Computer System Validation Engineer job opportunity at Zeiss Group.

Home Jobs In Portugal Tag: Job Computer System Validation Engineer position at Zeiss Group


DatePosted 30+ Days Ago bot
Zeiss Group Computer System Validation Engineer
Experience: 5-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation Lisboa, Portugal
loacation Lisboa....Portugal

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

Other Ai Matches

Duales Studium – Mechatronik (m/w/x), Beginn Herbst 2026 Applicants are expected to have a solid experience in handling Beginn Herbst 2026 related tasks
Training Specialist Applicants are expected to have a solid experience in handling Job related tasks
Head of Cyber Governance, Risk & Compliance (f/m/d) Applicants are expected to have a solid experience in handling Risk & Compliance (f/m/d) related tasks
Senior Expert Regulatory Affairs (m/f/x) Applicants are expected to have a solid experience in handling Job related tasks
Head of Sales & Service IQS Applicants are expected to have a solid experience in handling Job related tasks
Key Accounts Specialist Applicants are expected to have a solid experience in handling Job related tasks
Ausbildung – Chemielaborant (m/w/x), Beginn Herbst 2026 Applicants are expected to have a solid experience in handling Beginn Herbst 2026 related tasks
Praktikum Systems Engineering (m/w/x) Applicants are expected to have a solid experience in handling Job related tasks
C++ Technical Architect – Medical Device Software Applicants are expected to have a solid experience in handling Job related tasks
QC Applicants are expected to have a solid experience in handling Job related tasks
Pricing Consultant SAP Order-to-Cash (m/w/x) Applicants are expected to have a solid experience in handling Job related tasks
Head of Electron Optical Design (m/w/x) Applicants are expected to have a solid experience in handling Job related tasks
Business Process Excellence Manager-Procure to Pay Applicants are expected to have a solid experience in handling Job related tasks
Master Data Migration Expert (f/m/x) Applicants are expected to have a solid experience in handling Job related tasks
Tech Lead Applicants are expected to have a solid experience in handling Job related tasks
IQS Product Sales Manager Applicants are expected to have a solid experience in handling Job related tasks
Ingénieur Qualité Opérationnelle Junior (Fougères - 35300) F/H Applicants are expected to have a solid experience in handling Job related tasks
SAP Consultant Order to Cash (m/w/x) Applicants are expected to have a solid experience in handling Job related tasks
Marketing Manager (m/w/x) Applicants are expected to have a solid experience in handling Job related tasks
Manager, Senior Brand Applicants are expected to have a solid experience in handling Senior Brand related tasks
remote-jobserver Remote
Anterior Consumables Specialist, Sr Applicants are expected to have a solid experience in handling Sr related tasks
Prozessingenieur - Galvano- / Oberflächentechnik (m/w/x) Applicants are expected to have a solid experience in handling Job related tasks
Head of Software EUV Metrology (m/w/x) Applicants are expected to have a solid experience in handling Job related tasks