.jpg){kind=small}
Computer System Validation Engineer
On-site · Lisbon, Lisbon, Portugal
Job Summary
As a Computer System Validation Engineer, you will be responsible for ensuring computer systems comply with regulatory requirements. Responsibilities include developing validation plans and protocols, conducting risk assessments, executing validation tests (IQ, OQ, PQ), maintaining comprehensive documentation, and ensuring compliance with FDA and GxP standards. You will work closely with cross-functional teams and contribute to continuous improvement of validation processes. A degree in Engineering or Software is required, along with a minimum of 5 years experience in validation within a regulated industry.
Required Qualifications
- 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
- 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.
- Fluent in English; German is an advantage
Additional Requirements
- Diversity is emphasized and applications are encouraged regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.