CSV Engineer

Company Description

Eurofins Bio Pharma Product Testing B.V. is part of the international operating Eurofins Scientific. The organization is the largest Dutch contract laboratory for the pharmaceutical industry. We specialize in analytical tests for (bio) pharmaceutical raw materials, intermediates and (bio) pharmaceutical products. We perform a very diverse range of analyses for a large number of national and international clients within the (bio) pharmaceutical industry.

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.

Job description

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 junior or medior CSV Engineer with the following profile:

• Junior or medior level as CSV Engineer with approximately 2-7 years of experience;
• 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);
• Available for 36 to 40 hours a week, with a preference for fulltime;
• A professional level in English (C1 / C2), Dutch is considered a plus;
• You have to be located within reasonable distance of our site in Leiden and in possession of a valid Dutch work permit.

Additional Information

NBLSC and Eurofins: A world of possibilities

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. Eurofins NBLSC also offers:

• A competitive salary;
• Flexible working hours;
• 25 days of vacation (with the option to purchase 7 additional days);
• Travel allowance of 23 cents net per kilometer. Are you traveling by public transport? Then your travel expenses will be fully reimbursed via NS Business Card;
• Participation in a pension scheme with 50% contribution by Eurofins;
• Each month, you accumulate a choice budget balance of 8.25% of your gross salary. This includes, among other things, holiday pay and a year-end bonus. You can choose to have this amount paid out, or you can use it to buy extra days off, for example. You choose what suits you best;
• Discount on additional health insurance;
• Tax benefit via FiscFree when purchasing various products and services via your gross salary, such as a bicycle, sports contribution, fitness, mobile telephony, computers & tablets or a weekend away;
• Professional training and opportunities for training and development;
• Training options via the online learning platform Good Habitz.

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.

More about Eurofins Scientific

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2023, Eurofins generated 6.515 billion Euro proforma turnover in 900 laboratories across 62 countries, employing about 62,000 staff.