Computer System Validation (CSV) Specialist NL

QbD Group; Noord-Brabant; Presencial; EUR 45.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Tailored, transparent compensation

Knowledge-sharing and mentoring

Opportunity to shape future projects

Descripción de la vacante

A leading consulting firm in life sciences is seeking a Computer System Validation Specialist to ensure compliance and data integrity for GxP systems. You'll apply GAMP5 guidelines, collaborate with cross-functional teams, and manage validation activities. Ideal candidates have a degree in a scientific discipline, solid experience in the life sciences, and a passion for quality and compliance, along with strong problem-solving skills.

Formación

• Hands-on experience in the Life Sciences industry or software-driven projects.
• Understanding of GAMP5, USFDA 21 CFR Part 11, and Eudralex Annex 11.
• Ability to write and review user requirements and validation plans.

Responsabilidades

• Ensure that GxP-relevant systems are compliant and audit-ready.
• Collaborate across teams to elevate partnerships.
• Execute required tests and manage periodic reviews and revalidation.

Conocimientos

Attention to detail

Collaboration

Problem-solving

Technical understanding of IT systems

Project management skills

Educación

Bachelor’s or Master’s degree in a scientific or engineering discipline

Herramientas

Manufacturing Execution Systems (MES)

GAMP5 guidelines

Descripción del empleo

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