CSV Specialist

About MIGx

MIGx is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes and many others. 

MIGx interdisciplinary teams from Switzerland, Spain and Georgia have been taking care of projects in the fields of M&A, Integration, Application, Data Platforms, Processes, IT management, Digital transformation, Managed services and compliance.

Project Description

Our company is rapidly growing and now we are looking for a Computerized system validation (CSV) Specialist to join our team of professionals. For this role you should have a minimum of 5 years of experience in a relevant CSV role within the pharmaceutical, biotech or any other GxP regulated industry.

• Work closely with cross-functional teams to gather CSV requirements
• Prepare commissioning and validation documentation for new digital systems, platforms, and tools within R&D environments
• Lead and coordinate CSV activities, ensuring compliance with regulatory expectations while enabling agility in delivery
• Act as a bridge between the customer QA and the technical team
• Provide guidance and mentorship to team members, including training and coaching on CSV best practices
• Support agile project delivery by aligning with customers QMS and fast-paced R&D workflows
• Drive the continuous improvement of CSV strategies, leveraging digital tools and AI where appropriat

• Proven experience in CSV within a GxP-regulated environment, preferably with exposure to digital R&D systems
• Knowledge of regulatory frameworks (FDA, EU-GMP, Swissmedic) and standards (e.g., GAMP 5)
• Experience in quality assurance, risk management, deviation/CAPA handling, and data integrity best practices
• Strong analytical mindset with a structured and detail-oriented approach
• Excellent communication skills and ability to work in agile, cross-functional teams

• Experience in applying AI or data-driven approaches to CSV or quality assurance
• Proficiency in tools like Azure DevOps, Confluence, or SQL
• Knowledge of SAFe

• Professional
   

• 3 – 5 years

• English: B2+ 

• Hybrid work model and flexible working schedule that would suit night owls and early birds
• Excellent compensation package
• Attractive social benefits package
• 25 holiday days per year
• Free English classes 
• Possibilities of career development and the opportunity to shape the company’s future
• An employee-centric culture directly inspired by employee feedback - your voice is heard, and your perspective encouraged 
• Different training programs to support your personal and professional development
• Work in a fast growing, international company
• Friendly atmosphere and supportive Management team