Engineer Qualification - Equipment and Process (m/f/d)

Exyte; Nürnberg; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

A global technology company is looking for an Engineer Qualification to manage GMP-compliant qualification activities. The role involves coordination with suppliers and cross-functional teams while maintaining a proactive working style. Candidates should have a relevant degree, technical knowledge of regulations, and good communication skills in English and German. This position is based in Stuttgart and offers a mobile working option.

Leistungen

Onboarding event

Flexible mobile working

Subsidized fitness contract

Qualifikationen

• Completed studies in biotechnology, pharmaceutical or process engineering, medical devices or related field.
• Relevant technical knowledge of current regulations in qualification and validation.
• Experience with qualification/validation in the life sciences industry.

Aufgaben

• Responsible for handling project-specific qualification and validation activities.
• Preparing and reviewing qualification & validation documents.
• Coordinating communication between qualification and project management.

Kenntnisse

GMP compliance

Supplier coordination

Cross-functional communication

Fluent English

Good German

Ausbildung

Degree in biotechnology, pharmaceutical or process engineering

Jobbeschreibung

您的愿景雄心勃勃。这和我们一样。

我们的人才就是我们的成功。作为我们的一员，您将为未来高科技市场的卓越工程贡献力量，包括半导体、电池、制药、生物技术和数据中心等领域。在Exyte，您将成为一个全球性的挑战追求者社区的一部分，我们雄心勃勃，对创新充满热情。我们将携手共进，在公司悠久的历史基础上继续引领通往更美好世界的方向。

Discover your exciting role

Join our team as a Engineer Qualification(m/f/d)and take responsibility for GMP-compliant qualification activities, supplier coordination, and cross-functional communication.

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 CQV manager /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

Show your expertise

• 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 English. Good German skills are required
• Proactive and independent working style as well as a high level of quality awareness, efficiency and accuracy

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 Egym Wellpass at over 5,000 locations in Germany

Contact:

You want to be part of the Exyte team? We look forward to receiving your application!

For further questions and information, please do not hesitate to contact Katharina Hermann via E-Mail at [e-mail]

Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.

联系方式:

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