Computer System Validation (CSV) Specialist
Job Summary
Computer System Validation (CSV) Specialist
Location: Hybrid
Type: Full-time
QbD Groups team offers knowledge & tailored (software) solutions in development clinical regulatory & compliance production and distribution for companies active in Pharma ATMP and Medical Devices/IVD. We are always looking for the next QbDer in Software Solutions.
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
As a Software Validation Consultant you will play a critical role in managing and overseeing project deliverables for a variety of cutting-edge applications such as:
Automated systems
Software as a Medical Device (SaMD)
Mobile apps
From preparation and project design to implementation and follow-up you will provide full-cycle support to clients ensuring the successful delivery of projects.
You will also contribute to the integration and implementation of our proprietary QbD quality management software at client sites. With your knowledge of data integrity and quality management you will support companies across the Life Sciences including pharmaceuticals biotech medical devices and healthcarefrom large established firms to the most innovative start-ups.
What you bring
You hold a masters degree in a scientific or engineering field (e.g. bio-engineering bioinformatics industrial engineering civil engineering etc.).
You have some experience in the Life Sciences industry or with software-related projects.
You have a strong affinity with IT software and systems.
You have knowledge of data integrity.
You are detail-oriented eager to learn and adaptable to new challenges.
You possess strong technical and project management skills.
You are responsible with a strong analytical mindset and excellent problem-solving abilities.
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