Then we are looking for you for a temporary cooperation of initially 24 months, on a project of our customer, a renowned company in the pharmaceutical / biotech industry, in the southern greater Ulm area.
What you can do for us
- You coordinate, plan and process the validation of aseptic processes (media fills), downtimes as well as personnel qualifications and cleaning validations.
- You create, maintain and agree master validation plans, validation protocols/reports, risk analyses, regulations as well as associated deviations, amendments and measures as required.
- You will evaluate and summarise the relevant results of previously planned studies.
- You will assist in the preparation of regulatory documents and answer regulatory questions.
- You represent the complex technical topics in English in interdisciplinary project teams/meetings with internal and external partners as well as during audits and inspections by authorities.
- You are also responsible for coordinating the content with customers and interfaces, taking into account internal and global regulations as well as legal and official requirements.
- You take care of the planning, coordination and evaluation of further studies (internal/external) or assessments in coordination with the manager.
- You plan and coordinate your specialist topics within the team and also work on the topics in the global environment of the company association.
The skills that are needed
- You have a university degree (Bachelor) in the natural sciences or technical field and experience in the area of process validation, preferably aseptic processes.
- You already have several years of professional experience in the biopharmaceutical/pharmaceutical/process engineering sector
- You already have comprehensive GMP knowledge and knowledge of regulatory requirements
- Conversational English and German skills, both written and spoken
- Participation in on-call duty
Why you are in the right place when working with us
- Team spirit and diversity
- Work-life balance
- Attractive remuneration
- Employee benefits
- Numerous opportunities for training
- Team and sports events
- Global network
- Attractive employee referral program
Benefits may vary based on position and location. You can find an overview of our benefits under Careers and Benefits on our website.
We are looking forward to getting to know you.
Send us your application directly. We'll be happy to answer any questions you may have. We welcome applications from people who contribute to the diversity of our company.
Modis is a Smart Industry pioneer and leader. With over 30,000 employees in 20 countries, we support our clients and partners worldwide in the areas of IT and digital engineering. We are looking for talented people who will collaborate with us to drive innovation and digital transformation for an intelligent and sustainable future. Our employees are our top priority, and we believe that together we can achieve great things. That's why Kununu ranked us third among Germany's best employers in the consulting sector in 2021.
Phone +49 761/389080