Job Description
The position of Computer Systems Validation (CSV) Engineer resides within the Validation, Maintenance and Calibration (VCM) department. The team is responsible for ensuring equipment is qualified throughout its lifecycle to the necessary requirements. The department works with teams that function on the local Leiden site, Benelux regional and global levels.
The department in 2025 will be migrating a large number of laboratory equipment to a new IT environment. The key focuses of the role are to conduct the process of transition to the new IT environment alongside organising and carrying out scheduled tasks to ensure equipment compliance to pharmaceutical guidelines.
The core tasks as CSV Engineer include:
- Carrying out validations/qualifications/verifications of new instruments and existing instruments after significant changes (IQ/OQ/PQ).
- Writing accurate instructions for the use and maintenance of instruments.
- Providing instrument training to colleagues.
- Carrying out periodic maintenance and/or calibrations of instruments in accordance with the planning.
- Communicating planned maintenance on time with Team Leaders.
- Reporting malfunctions of equipment (and utilities).
- Troubleshooting problems that do not require an external supplier.
- Ensure that instrument logbooks are completed adequately and accurately in the event of maintenance and disruptions.
- Maintaining contact with external suppliers in the event of malfunctions and external maintenance and/or calibrations.
- Guiding technicians and suppliers regarding equipment and technical facilities.
- Coordinating with the system admins to implement necessary software updates for laboratory equipment.
- Providing feedback to colleagues in a constructive manner to help future work run more smoothly.
- Working according to approved procedures and reporting and drawing up deviations.
- Cooperating with inspections and audits.
- Following safety instructions and actively becoming aware of them.
- Implementing the ARBO policy and reporting emergencies.
Qualifications
We are looking for a CSV Engineer with the following profile:
- A completed MBO or HBO education within a laboratory or IT field;
- At least 2 years of experience with technology and equipment preferred within a laboratory environment;
- At least one year of experience in performing software qualifications to meet GAMP and USP guidelines is desired;
- Comfortable with a high level of autonomy within your role. Your assigned tasks have to be prioritized by you and you control your own planning;
- Working with multiple stakeholders such as Managers, IT, finance, QA;
- Initiate project plans in collaboration with stakeholders;
- Flexible in dealing with urgent requests, sometimes also outside office hours (which can be compensated);
- A professional level in English (C1 / C2), Dutch is considered a plus;
Additional Information
This position is based at Eurofins NBLSC (part of Eurofins PROXY Laboratories B.V.) on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input.
Working at Eurofins NBLSC offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees:
- Diverse developmental opportunities within the organization;
- A large client portfolio ensures a lot of diversity in your work.