Qualification Engineer focus Cleanroom (m/f/d)

TN Germany; Nürnberg; Vor Ort; EUR 40.000 - 80.000; Vollzeit

Zusammenfassung

Join a forward-thinking company as a Qualification Engineer, focusing on Cleanroom projects in the Bio Life Sciences sector. This role offers the chance to work on exciting pharmaceutical projects, ensuring compliance with GMP regulations and contributing to innovative solutions. You'll collaborate with a passionate team, driving projects forward while enjoying flexible working options. With a commitment to sustainability and engineering excellence, this position provides a unique opportunity to make a meaningful impact in high-tech industries. If you're proactive and eager to grow in a dynamic environment, this role is perfect for you.

Leistungen

Onboarding event for new colleagues

Spacious ergonomic workstations

Buddy system for familiarization

Flexible mobile working options

Free coffee and water

Subsidized fitness programs

Qualifikationen

• Degree in biotechnology, pharmaceutical, or related field required.
• Knowledge of GMP, ISO, and data integrity regulations is essential.

Aufgaben

• Handle qualification and validation activities according to GMP regulations.
• Prepare and review qualification documents and oversee execution.

Kenntnisse

Qualification and Validation

GMP Regulations

English Fluency

German Language Skills

Project Management

Ausbildung

Degree in Biotechnology

Degree in Pharmaceutical Engineering

Degree in Process Engineering

Jobbeschreibung

Qualification Engineer focus Cleanroom (m/f/d), Nuremberg

Client:

Exyte

Location:

Nuremberg, Germany

Job Category:

-

EU work permit required:

Yes

Job Reference:

00d74f93b230

Job Views:

1

Posted:

30.04.2025

Expiry Date:

14.06.2025

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 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 and more sustainable engineering.

As (Junior) Project Engineer (m/f/d) Pharma / Food with focus on Qualification / Validation, you work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification & Validation. You will be assigned to our regional office in Nuremberg and work on-site with our clients to qualify equipment and facilities. You will join a team of experienced qualification & validation engineers working on exciting pharma projects. Mobile working may be possible depending on the project.

Responsibilities

• Handle project-specific qualification and validation activities according to current GMP regulations for HVAC, Cleanroom, and Clean Media Systems.
• Prepare and review qualification & validation documents (specifications, risk analysis, plans, and reports).
• Prepare test protocols for qualification stages (DQ, IQ, OQ, PQ) and oversee their execution.
• Coordinate with suppliers and review their documentation (FAT/SAT, technical documents).
• Communicate between qualification teams, clients, technical engineers, automation, QA, and suppliers; report to the CQV manager/project management.
• Coordinate and conduct qualification activities on-site, working independently under time pressure to drive projects forward.

Qualifications

• Degree in biotechnology, pharmaceutical, process engineering, medical devices, or a related field.
• Knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity, ISO14644).
• Initial experience in qualification/validation, ideally in the life sciences industry, gained through employment or internships.
• Fluent in English; good German skills are required.
• Proactive, independent work style with high quality, efficiency, and accuracy standards.

What We Offer

• Onboarding event for new colleagues.
• Spacious, ergonomic workstations at attractive locations.
• Buddy system for familiarization with the team.
• Flexible mobile working options.
• Free coffee and water dispensers.
• Subsidized fitness programs through Qualitrain at over 5,000 locations in Germany.

#ExyteCareersAreExciting

Contact and Equal Opportunity

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