Lead Consultant IT Compliance / CSV (m/f/d)

Discover your exciting role

 As Lead Consultant IT Complicance - Computer System Validation (m/f/d) you work in the Bio Life Science Sector at Exyte and in top projects on-site with our clients in the department Commissioning, Qualification & Validation - throughout Germany and Europe. 

Explore your tasks and responsibilities

• Management and implementation of software validation and infrastructure qualification projects in the regulated life science environment

• Consulting, coaching and development of IT quality management concepts

• Introduction of CSV concepts into existing quality management systems (CSV policies, SOPs, validation master plans, etc.)

• Conducting workshops, GAP assessments and IT compliance audits as well as implementing and processing of CAPA plans

• Independent creation of life cycle validation and qualification documents for computer-aided or automated systems

• Validation and qualification of IT infrastructure and IT services as well as support in the acquisition of customer projects

Show your expertise

• Completed academic training in natural sciences or engineering (computer science, automation technology, engineering, pharmaceutical technology or in a comparable field of study)

• Several years of work experience in the field of computer system validation and IT infrastructure qualification in the life science industry

• In-depth knowledge of the underlying requirements (EU-GMP guidelines, 21 CFR Part 11/210/820, ISO13485, MDR etc.)              

• Willingness to familiarize yourself with various software applications

• Flexibility, willingness to travel in German-speaking countries and a high level of service orientation

• Fluent use of both German and English is required

What we offer you

• Your start at Exyte: Take part in a two-day onboarding event with new colleagues

• Attractive location: Our location in Stuttgart features spacious workstations with height-adjustable desks

• Buddy-System: Several weeks of close familiarisation with your colleagues in the team

• Work-life balance: There is always the possibility of switching to mobile working

• Catering: Free coffee specialities as well as water dispensers are accessible on every floor

• Keep fit: Exyte subsidises your fitness contract through EGym Wellpass at over 5,000 locations in Germany