System Validation Engineer
BUILD THE FUTURE OF MOBILITY WITH US!
Our history lies in the development of vehicles and their software. Today, however, mobility solutions are no longer limited to classic vehicles, the vehicle itself is becoming an IoT device. Work with us on innovative solutions, such as digital access systems, self-driving vehicles, climate-neutral mobility or the next generation operating system. As a strong software house, we are helping to shape this path, be part of it!
What we are looking for?
We are looking for a Computer System Validation Engineer that will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. We are seeking an enthusiastic and experienced Lab CSV Engineer to join our team on a long-term contract basis. The Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. The position will work within a collaborative Computerised Instruments team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative. Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
- Minimum 3 years’ experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
- Experience of analyzing and challenging s/w to identify gaps. Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
- Self-motivated, detail-oriented, and excellent organizational and time management skills
- Capable of relating well to other people with whom s/he comes in contact, both within and outside of the laboratory area
Role will involve:
- Manage lab equipment validation projects from software install to business release
- Prioritize CSV activities in line with the project schedule and monitor budgets
- Generate computer system validation documentation, e.g. Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
- Review of software release notes
- Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
- Determine any specific configurations for the software, e.g. how data is saved and named
- Understand and define user permissions
- Execute test scripts, analyse test results and determine the acceptability of results against pre-determined criteria
- Work with the business to identify and implement procedural controls to mitigate issues found during testing
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices
- Determine solutions or recommendations for changes and/or improvements
- Produce documentation that is well written and consistent throughout the document body e.g. headings, font type, font size, paragraph spacing, text alignment, correct tense
- Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
That's what we offer you:
- The 13th salary
- 26 standard vacation days - for a good work-life balance
- Full private health insurance package for you and one of your relatives
- Meal tickets
- Gift cards for Christmas and Easter
- Remote working
- E-learning platforms
INTERESTED? Then apply now. If you have any questions, you can contact us at any time.
Oana-Alexandra Toda Alexandra-Ioana Luca
Technical Recruiter Technical Recruiter
+40 771 789 887 +40 771 789 601
+40 771 447 695