QbD Group 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 QbD’er in **Software Solutions**_**.**_
**What do we expect from you as a Senior CSV Specialist?**
- 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 **bachelor’s degree in Life Sciences field** (e.g., bio-engineering, bioinformatics, chemistry, pharmaceutical chemistry, etc.).
- You have at least 6 years of **experience in the Life Sciences industry with software-related projects (MES systems by Critical Manufacturing)**.
- You have knowledge in FDA, Annex 11 requirements and good knowledge of GAMP 5 guidance.
- You are **proficient** in spoken and written **English for dealing with U.S. customers**:
- 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, leadership and project management skills**.
- You are responsible, with a strong analytical mindset and excellent problem-solving abilities.
- You are self managed and **capable of organizing and supervise activities and assign tasks in groups of 2 to 5 members.**
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.
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 shortWe stand for? **JPEG**:J*oy in**P**artnership, going for the**E**xtra mile to**G*et things done!
Pay: Up to $25,000.00 per month
Work Location: Hybrid remote in 11510, Polanco I Sección, CDMX

📌 Senior Computer System Validation (Csv) Specialist (Polanco I Sección)
🏢 QbD Group
📍 Polanco I Sección