Lead Engineer Qualification (m/f/d)

Discover your exciting role

Exyte is a global leader in the design, engineering and delivery of complex pharmaceutical plants and facilities.

As Lead Engineer Qualification (m/f/d), you work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification (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.

Explore your tasks and responsibilities

• You are responsible for handling the project-specific qualification and validation activities according to current GMP regulations in cleanrooms and media

• 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

Show your expertise

• 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

Was wir Ihnen bieten

• Ihr Start bei Exyte: Nehmen Sie an einer zweitägigen Onboarding-Veranstaltung mit neuen Kollegen teil

• Interessante Projekte: Sie arbeiten u.a. in einem der Leuchtturm Projekte in der Industrie mit und erschaffe hochmoderne und hochkomplexe Pharmaanlagen

• Attraktiver Standort: Unser Standort weist großzügige Arbeitsplätze mit höhenverstellbaren Schreibtischen auf

• Buddy-System: Mehrwöchige enge Einarbeitungsphase mit Ihren Kollegen im Team

• Work-Life-Balance: Es besteht die Möglichkeit immer wieder in das mobile Arbeiten zu wechseln

• Verpflegung: Kostenlose Kaffeespezialitäten sowie Wasserspender sind auf jedem Stock erreichbar

• Halten Sie sich fit: Exyte bezuschusst über EGym Wellpass an über 5.000 Standorten in Deutschland Ihren Fitnessvertrag