Qualification & Validation Engineer F/M/X
As a Qualification & Validation Consultant you will get the chance to work in a multi-national environment and develop your expertise by working on diverse projects.
ROLES & RESPONSIBILITIES
Reporting to the project leader and working in close collaboration with a team of Qualification and Validation experts, you will have the following responsibilities:
- Create user requirements (URS)
- Define the validation strategy based upon the clients’ guidance and benchmarks
- Build validation and qualification plans
- Coordinate and perform FAT/SAT as well as equipment commissioning
- Execute tests (IQ/OQ/PQ/DQ)
- Coordinate and review the related GMP documentation needed for change control
- Ensure the planning of validation and qualification strategies in accordance with all the concerned parties (production/QA/maintenance)
- Ensure the operational management of the technicians dedicated to the validation
- Maintain equipment to support GMP manufacturing
- Foster innovation and continuous improvement on process, and on qualification and validation projects
THE IDEAL PROFILE
- You hold at least a master’s degree in engineering, bioengineering, biology, pharmacy or related fields.
- You hold at least one year of experience in qualification / validation in GMP environment.
- You are familiar with the processes and legal requirements for pharmaceutical industry.
- You have technical understanding of manufacturing equipment (autoclaves, washing machines...) and processes specific to Pharmaceutical manufacturing preferred.
- You are familiar with creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ).
- You are proactive, have good communication skills, and can work in a multidisciplinary team towards a common goal.
- You are proficient in French and English. Dutch is a plus.
6 advantages of joining Amaris Consulting:
- An international learning environment where you can develop your knowledge on different subjects and areas.
- In-depth training so that you can gain more technical skills.
- Certifications that will allow you to gain a competitive edge.
- An R&D Lab that will give you the opportunity to develop your skills that you can then use on innovative projects
- Opportunity to pitch your ideas to help us grow a successful business
- Regular coaching and mentoring provided by our Senior Technical Consultants who will allow you to become, in turn, an expert in your profession.
- An attractive, tailor-made and evolving career path
What about my salary?
It all depends on your profile and your skills, but we offer a fixed salary in line with the market and scalable throughout your career with us.
Most importantly, you'll be part of an independent company that values:
Agility: we are flexible, dynamic and offer a stimulating environment.
International: daily international exchanges and mobility opportunities around the world.
Intrapreneurship: if you want to invest in related topics or develop a Business Unit, Amaris is for you!
Supportive Leadership: with a limited number of consultants, your manager will adapt to your profile and accompany you throughout your professional journey!
Still not convinced ? Because we are committed to giving meaning to our daily actions, Mantu is committed to sustainability (reduction of our carbon footprint, collaboration with various associations, diversity and inclusion policy).