Computer System Validation (CSV) Specialist NL

Computer System Validation (CSV) Specialist NL

Are you passionate about ensuring that computerized systems in life sciences are compliant, reliable, and audit-ready? Do you enjoy working at the intersection of technology, quality, and regulations?

We are looking for a

Computer System Validation (CSV) Specialist

who’s ready to dive into the world of GxP systems and play a vital role in ensuring compliance, integrity, and reliability — from implementation to audit. You’ll apply

GAMP5 principles

and champion

data integrity

across the full system lifecycle, helping clients meet the highest regulatory standards with confidence.

This role is perfect for someone who’s energized by solving complex challenges, enjoys collaborating across teams, and isn’t afraid to go the extra mile to deliver results that matter. If you’re ready to make an impact — and grow while doing it — we’d love to hear from you.

What’s in it for you?

Make a real impact:

Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts:

Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career:

As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package:

We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

What you’ll be doing

Take ownership of validation activities from start to finish — ensuring every GxP-relevant system is set up and running in

full compliance

Apply

GAMP5 guidelines

using a risk-based approach with quality and clarity

Write and review user requirements, validation plans, protocols, reports and risk assessments regarding computerized systems with precision, knowing the details make the difference

Champion

data integrity

across everything you do, embedding ALCOA+ principles into both systems and culture

Collaborate with QA, IT, engineering, and operations and elevate

partnership

Planning

periodic reviews

and revalidation , ensuring our systems remain reliable and inspection-ready

Execute

the required tests in collaboration with Production, QC

Be the go‑to expert during audits and inspections, confidently representing the work you stand behind

Tackle

change controls

with a can‑do attitude, maintaining validated status without losing momentum

Assess supplier provided software systems with a critical yet constructive eye — making sure external solutions align with our internal standards

Share your knowledge generously by

training and guiding colleagues

— helping others grow while you do the same

What you bring

You hold a

Bachelor’s or Master’s

degree in a scientific or engineering discipline (e.g., bio-engineering, bioinformatics, industrial or civil engineering) — and you're eager to put it to meaningful use

You bring hands‑on experience in the

Life Sciences industry

or in software‑driven projects, where compliance and quality matter

You feel at home working with

IT systems, software , and especially

Manufacturing Execution Systems (MES)

— you don’t just use them, you understand how they work and why they matter

You have a solid understanding of

related guidelines

(GAMP 5 (ISPE), USFDA 21 CFR Part 11 en Eudralex Annex 11) and know how to apply them in a regulated environment

You are detail‑oriented by nature, curious by instinct, and embrace change as an opportunity to grow

You combine

technical know‑how

with a practical, can‑do approach to

project management

— you like to move things forward

You take ownership of your work, approach problems with a clear and analytical mindset, and enjoy finding solutions that stick

Most of all, you enjoy working with others, learning from different perspectives, and contributing to a team that gets things done — together

Who you are

Our culture is driven by values If this sounds like you, you’ll fit right in:

You’re

resilient

and tackle challenges with a positive mindset

You’re

curious

and always up for learning something new

You have a

no non‑sense approach

honest, clear, respectful

You’re

innovative

and bring ideas, not just opinions

And above all, you’re

serious about your work, but not too serious about yourself

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in

JPEG :

Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

Send us your CV and motivation letter. You could be the next one to join the QbD family.

Seniority level

Associate

Employment type

Full-time

Job function

Consulting

Industries

Business Consulting and Services

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