Computer System Validation (CSV) Specialist NL

TRIUM Clinical Consulting NV; Breda; On-site; EUR 45.000 - 75.000; Full time

Job summary

Join a pioneering company that offers tailored software solutions in the Life Sciences sector. As a Software Validation Consultant, you'll oversee project deliverables for cutting-edge applications, from automated systems to mobile apps. Your role will involve providing full-cycle support, ensuring successful project delivery while integrating proprietary quality management software. This innovative firm values continuous learning and fosters a joyful community where you can thrive. If you are detail-oriented and passionate about technology, this opportunity is perfect for you.

Benefits

Attractive salary package

Job security

Continuous learning and development

Global success story participation

Qualifications

• Master’s degree in bio-engineering, bioinformatics, or similar required.
• Experience in Life Sciences or software-related projects preferred.

Responsibilities

• Manage project deliverables for automated systems and software.
• Provide full-cycle support from project design to implementation.

Skills

Project Management

Data Integrity

Analytical Skills

Problem-Solving

Software Development

Education

Master’s Degree in Scientific Field

Job description

QbD Groupteam 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 QbD’er in Software Solutions.

What do we expect from you as a CSV Specialist?

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 healthcare—from large, established firms to the most innovative start-ups.

Who are we looking for?

• You hold a master’s 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.

A true QbD’er can be recognized by the following qualities:

• Resilient: Your strong and positive attitude helps you overcome any challenge
• Hungry for knowledge: You are always open to learning
• No non-sense mentality: you can be straightforward in a respectful way
• Innovative: You are constantly looking for new and better solutions
• (Not too) serious: your job is serious, but you don’t take yourself too serious.

What’s in it for you?

• QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
• In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!