Lead Engineer Qualification (m/f/d)

Exyte; Stuttgart; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Exyte, a global leader in designing and engineering facilities, is seeking a Lead Engineer Qualification for their Bio Life Sciences sector in Stuttgart. The position involves collaborating with engineers across various regions to manage qualification activities, ensuring compliance with regulations while promoting efficiency and quality in high-tech environments.

Leistungen

Onboarding event for new colleagues

Flexible mobile working options

Subsidized fitness contracts through Egym Wellpass

Qualifikationen

• Degree in related fields is mandatory.
• Initial experience in the life sciences industry preferred.
• High quality standards, efficiency, and accuracy are essential.

Aufgaben

• Handle project-specific qualification and validation activities according to GMP regulations.
• Prepare and review qualification & validation documents.
• Coordinate with suppliers and communication among teams.

Kenntnisse

Knowledge of qualification and validation regulations

Fluency in English

Good German skills

Proactivity

Independence

Ausbildung

Degree in biotechnology, pharmaceutical, process engineering, medical devices or related fields

Jobbeschreibung

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Client:

Exyte

Location:

Stuttgart, Germany

Job Category:

Other

EU work permit required:

Yes

Job Reference:

7e276fd225b8

Job Views:

2

Posted:

15.06.2025

Expiry Date:

30.07.2025

Job Description:

Your vision is ambitious. Just like ours.
Our people are our success. As one of us, you will contribute to engineering excellence for high-tech markets such as semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community passionate about innovation, building a better world.

Discover your exciting role

Exyte is a global leader in designing, engineering, and delivering facilities for high-tech industries, focusing on energy efficiency and sustainability.

As Lead Engineer Qualification (m/f/d), you will work in the Bio Life Sciences sector at Exyte Central Europe, reporting to the Group Lead Qualification & Validation. You will collaborate with highly qualified engineers across regions like Stuttgart, Nürnberg, Penzberg, Leverkusen, and onsite with clients to qualify equipment and facilities. Mobile working options are available depending on the project.

Responsibilities include:

• Handling project-specific qualification and validation activities according to GMP regulations
• Preparing and reviewing qualification & validation documents (specifications, risk analysis, plans, reports)
• Creating test protocols for qualification stages (DQ, IQ, OQ, PQ) and overseeing their execution
• Coordinating with suppliers and reviewing their documentation (FAT/SAT, technical docs)
• Communicating between qualification teams, clients, technical engineers, automation, QA, and suppliers; reporting to CQV manager/project management
• On-site coordination and execution of qualification activities, working under time pressure to drive projects forward

Qualifications:

• Degree in biotechnology, pharmaceutical, process engineering, medical devices, or related fields
• Knowledge of qualification and validation regulations (GMP, ISO, 21 CFR, Annex 15, data integrity)
• Initial experience in qualification/validation, ideally in the life sciences industry
• Fluent in English, good German skills required
• Proactive, independent, with high quality standards, efficiency, and accuracy

What we offer:

• Onboarding event for new colleagues
• Spacious workstations with height-adjustable desks in Stuttgart
• Buddy-System for team integration
• Flexible mobile working options
• Free coffee and water dispensers
• Subsidized fitness contracts through Egym Wellpass

#ExyteCareersAreExciting

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Contact:

Exyte is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified candidates regardless of background or identity.

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