CSV Engineer (Computer System Validation) - M/F/X

Amaris Consulting Sàrl

Geneva

Key information

Publication date:28 November 2025
Workload:100%
Place of work:Geneva

Job summary

Amaris Consulting is an independent consulting and technology company. Join a global team of 7,600 talents across 60+ countries!

Tasks

Draft and review the entire CSV documentation set.
Validate critical systems like Veeva eQMS and Cloud/SaaS.
Support teams in clarifying requirements and conducting tests.

Skills

Bachelor's degree in engineering or a related field required.
1-3 years of experience in CSV within a regulated environment.
Bilingual in French and English (B2+ level required).

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Who are we?

Amaris Consulting is an independent consulting and technology company serving businesses. With over 1000 clients worldwide, we have been deploying solutions for the largest projects for more than a decade - all made possible by an international team of 7,600 talents spread across 5 continents and more than 60 countries. Our solutions focus on four different areas of activity: Information systems and digital, telecommunications, life sciences, and engineering. We aim to create and develop a community of talents where all team members can reach their full potential. Amaris is your "stepping stone" to cross the rivers of change, to take on challenges, and to successfully complete all your projects.

At Amaris, we are committed to offering our candidates the best possible recruitment experience. We seek to better know and understand our candidates, challenge them, and share our feedback as quickly as possible. Here is what our recruitment process looks like:

First contact: Our process usually starts with a brief virtual/phone conversation to learn more about you! The goal? To get to know you, understand your motivations, and ensure we offer you the position that best suits you!

Interviews (on average, the number of interviews is 3 – but it may vary depending on the seniority level required for the position). During the interviews, you will meet members of our team: your future manager of course, but also other people you will work with. These interviews will allow us to learn more about you, your experience and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our history, our teams, and your career opportunities!

Case study: Depending on the position, you may be asked to take a test. This could be a role play, a technical evaluation, a problem-solving scenario, etc.

As you know, every person is different and the same goes for every role in a company. That is why we must adapt accordingly, so the process can sometimes be somewhat different for each candidate. That said, we always put ourselves in the candidate's shoes to offer the best possible experience. We look forward to meeting you!

Job description

Amaris is currently looking for a Automation & CSV Engineer to join its teams in the canton of Vaud in Switzerland.

🔥 Your responsibilities:

Write and review the entire CSV documentation set: URS, Validation Plan, IQ/OQ/PQ Protocols, validation reports, Impact Assessments, Risk Analyses (GAMP 5).
Ensure validation of critical systems: Veeva eQMS, Veeva eDMS (mandatory), Cloud/SaaS systems, Excel spreadsheets.
Participate in projects for implementation, migration, or optimization of quality systems.
Support business teams (Quality, IT, R&D) in clarifying requirements and conducting tests.
Apply Data Integrity (ALCOA+) principles and ensure regulatory compliance of systems.
Propose process improvements, tools, and templates to enhance the efficiency of the validation cycle.

🎯 Your profile:

Bachelor's degree in engineering, computer systems, sciences, or equivalent scientific field.
1 to 3 years of experience in Computer System Validation (CSV) in a regulated environment (pharma, biotech, medical devices).
Experience in Switzerland mandatory (reference to be provided).
Mastery of standards: GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+.
In-depth knowledge of Veeva eQMS / eDMS – ideally on an implementation or migration project.
Experience in validation of Cloud/SaaS systems and Excel spreadsheets (a plus).
Bilingual French/English (B2+ written/spoken level).
Rigor, autonomy, hands-on approach, and continuous improvement mindset.

💡 Our company culture:

Agility: Work in a flexible, dynamic, and stimulating environment.
International: Benefit from international collaborations and numerous mobility opportunities.
Intrapreneurship: Get involved in parallel initiatives or develop your own Business Unit.
Supportive management: Receive personalized support throughout your professional journey.

Amaris Consulting is committed to diversity and inclusion. We encourage applications from all qualified individuals regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.

Apply now and join our team for a rewarding and stimulating career!