CQV Manager - Process Qualification (m/f/d)

Discover your exciting role

Exyte is a global leader in the design, development and project execution of pharmaceutical plants for the life science industry. The position of the CQV Manager - Process Qualification (m/f/d) is located in the Bio Life Sciences division of Exyte Central Europe and reports to the Team Lead Qualification and Validation. You will work at Exyte's office in Leverkusen as well as on-site at our customers' facilities to test the relevant equipment and devices. Together with your teammates, you will work on projects in medium-sized and large industrial companies.

The place of work is Leverkusen. You will work in phases at the customer's site (Germany-wide) and in the Exyte office. In addition, there is the possibility of mobile working.

Explore your tasks and responsibilities

• You lead a group of 4 to a maximum of 10 employees, both technically and disciplinary
• You are responsible for the project-specific qualification and validation activities according to current GMP regulations
• You are responsible for leading project teams and for reporting to the project management / project controlling and to the customers
• You advise our customers on qualification and validation concepts, which you then implement on site in the final project phase
• You create test plans for the different qualification phases DQ, IQ, OQ and PQ and are responsible for the execution and the monitoring of the tests
• You act as an interface between different stakeholders and ensure a smooth communication between them
• During the commissioning and implementation phase of the qualification you are at the customer´s site to coordinate the qualification activities independently. In doing so, you are able to act under time pressure and successfully drive the project forward
• You use new network developed during the project work for further acquisition activities

Show your expertise

• You have a degree in biotechnology, pharmaceutical engineering, process engineering, medical engineering, facility management & engineering or a similar course of study, alternatively you have many years of professional experience
• You have at least 4 years of professional experience in the field of qualification & validation (ideally of equipment and/or process plants)
• You have experience in leading employees, also in a project environment
• You have relevant technical knowledge of the current regulations for qualification & validation (GMP guidelines, ISO, 21 CFR, Annex 15, data integrity) and are experienced in project management
• You are fluent in German, as the project environment is mainly German speaking and the documentation is mainly done in German. In addition, you have very good English language skills  
• You like to act proactively, work in a highly quality-conscious and accurate manner, as well as independently and efficiently

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 Qualitrain at over 5,000 locations in Germany