Engineer Cleanroom Qualification (m/f/d)

Exyte; Nürnberg; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading engineering firm is seeking an Engineer Cleanroom Qualification to oversee project-specific qualification and validation in the Bio Life Sciences sector. Key responsibilities include preparing necessary documentation and conducting on-site qualifications. Candidates should have a degree in biotechnology or scientific engineering and fluency in English, with good German skills being a plus. The position offers an opportunity for mobile working and other attractive benefits.

Leistungen

Onboarding event

Flexible working location

Fitness contract subsidy

Qualifikationen

• Experience with qualification/validation in life sciences industry.
• Knowledge of data integrity and ISO standards is important.

Aufgaben

• Handle project-specific qualification and validation activities.
• Prepare and review qualification and validation documents.
• Execute test protocols for different qualification stages.
• Coordinate communication between stakeholders.
• Independently conduct on-site qualifications.

Kenntnisse

Technical knowledge of GMP regulations

Fluent English communication skills

Good German skills

Proactive working style

Quality awareness

Ausbildung

Degree in biotechnology, pharmaceutical engineering or related field

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

As Engineer Cleanroom Qualification (m/f/d), you work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification. You are going to be assigned to our regional office in Nuremberg 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 exiting pharma projects. 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 for HVAC‑, Cleanroom‑ & Clean Media‑Systems
• 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, ISO14644)
• 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:

Exyte是一个平等就业机会雇主，并致力于提供平等机会和公正待遇。因此，Exyte集团为所有合格的申请者提供平等的就业机会，无论其血统、性别、性取向、性别认同、种族、肤色、宗教、受保护的退伍军人身份、残疾状态或遗传信息如何。