Junior Project Engineer Qualification / Validation (m/f/d)
Ver: 143
Día de actualización: 22-10-2024
Categoría: Alta tecnología Mecánica / Técnica Eléctrica / Electrónica IT - Software
Industria: Civil Engineering
Posición: Entry level
Tipo de empleo: Full-time
Contenido de trabajo
Your vision is ambitious. Just like ours.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.
Discover your exciting role
Exyte is a global leader in design, engineering and delivery of facilities for high-tech industries - serving people and planet by energy saving & more sustainable engineering.
As Junior Project 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. You are going to work in our regional office in Penzberg and 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 in the south of Germany and in Austria. Mobile working is also a possibility, depending on the project.
Explore Your Tasks And Responsibilities
- Responsible handling of project-specific qualification and validation activities according to current GMP regulations
- Preparation and review of qualification & validation documents (specifications, risk analysis, plans and reports)
- Preparation of test protocols for different qualification stages (DQ, IQ, OQ, PQ) and being responsible for their execution
- Responsible for supplier coordination and review of supplier documentation (FAT/ SAT, technical documents)
- Responsible for the communication between qualification, customer/user, technical engineers, automation, QA, and suppliers as well as reporting to the project management
- During the implementation phase, you are on-site to coordinate and conduct the qualification independently. You are able to work under time pressure and to successfully drive the project forward
- Completed studies in the field of biotechnology, pharmaceutical or process engineering, medical devices or a related field of study
- Relevant technical knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity)
- You have gained a first insight into qualification/validation during your first job or during an internship (ideally in the life sciences industry)
- Fluent written and oral communication skills in German, since the documentation language is German. Good English skills are required
- Proactive and independent working style as well as a high level of quality awareness, efficiency and accuracy
Plazo: 06-12-2024
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