Exyte GmbH
Location
Penzberg | Germany
Job description
Our people are our success. As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community of challenge seekers who are ambitious and passionate about innovation. Together, we will build on our company’s long history and keep on leading the way to a better world.
Exyte is a global leader in the design, engineering and delivery of complex pharmaceutical plants and facilities.
As Senior Engineer Qualification & Validation (m/f/d), you work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification & Validation (m/f/d). You are going to work in our regional office in Penzberg and mainly with our clients on-site to qualify the respective equipment and facilities. In a team of highly qualified and experienced qualification & validation engineers you will be covering projects mainly within Germany. Mobile working is also a possibility, depending on the project.
You are responsible for handling the project-specific qualification and validation activities according to current GMP regulations
You oversee the GMP consulting for the planning of pharmaceutical plants and the development and implementation of qualification concepts
You create qualification & validation documents, test plans and reports (FAT/ SAT, DQ, IQ, OQ, PQ) and you execute and coordinate GxP reviews and risk analyses
You act as the interface between qualification, technical engineers, suppliers and report to the customer as well as project management
You are responsible for the assessment and implementation of change and deviation management (CAPA) as well as CAPA tracking and monitoring
You completed your studies in the field of biotechnology, food technology, pharmaceutical or medical technology or a related field of study successfully
You have at least 4 years of professional experience in the life science industry with profound knowledge in qualification & validation and/or engineering and commissioning of process plants / clean rooms / media systems
You are experienced in project management and in applying the relevant technical knowledge and current regulations
You speak German fluently and your English skills are good
Proactive commitment to customers as well as a quality-oriented and independent way of working are self-evidently to you
You are willing to work on-site with our clients
Your start at Exyte: Take part in a two-day onboarding event with new colleagues
Attractive location: Our location 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
Job tags
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