Computer System Validation (CSV) Specialist NL
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Job Location:
Breda - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Computer System Validation (CSV) Specialist
Location: Hybrid NL
Type: Full-time
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 whos ready to dive into the world of GxP systems and play a vital role in ensuring compliance integrity and reliability from implementation to audit. Youll 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 whos energized by solving complex challenges enjoys collaborating across teams and isnt afraid to go the extra mile to deliver results that matter. If youre ready to make an impact and grow while doing it wed love to hear from you.
Whats 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 youll 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 Bachelors or Masters degree in a scientific or engineering discipline (e.g. bio-engineering bioinformatics industrial or civil engineering) and youre 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 dont 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 youll fit right in:
- Youre resilient and tackle challenges with a positive mindset
- Youre curious and always up for learning something new
- You have a no non-sense approach honest clear respectful
- Youre innovative and bring ideas not just opinions
- And above all youre serious about your work but not too serious about yourself
About us
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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.
Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.
