Project Engineer Cleanroom Qualification (m/f/d)

Exyte; Stuttgart; Hybrid; EUR 50.000 - 65.000; Vollzeit

Zusammenfassung

Exyte在斯图加特招聘初级项目工程师，专注于制药/食品行业的资格与验证。该职位涉及生物生命科学领域的项目，主要职责包括负责项目的资格和验证活动，并与客户现场合作。应聘者需具备相关领域学位、流利的英语与良好的德语能力，独立工作能力强。

Leistungen

免费咖啡

健身合同补贴

灵活的工作安排

Qualifikationen

• 完成生物技术、制药或过程工程的学位。
• 通过实习或第一份工作获得有关资格/验证的初步见解。
• 了解当前资格和验证中的技术知识(例如GMP、ISO)。

Aufgaben

• 按照GMP法规负责项目特定的资格和验证活动。
• 准备和审查资格和验证文件（规范、风险分析、计划和报告）。
• 协调供应商并审查供应商文件（FAT/SAT，技术文档）。

Kenntnisse

流利的英语书写和口语

良好的德语能力

独立工作

Ausbildung

生物技术、制药或过程工程学位

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

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 (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 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

联系方式:

Would you like to become part of the Exyte team? Then we look forward to your application!For questions and further information, please do not hesitate to contact us by email [e-mail] Central Europe GmbHKatharina HermannLöwentorstrasse 4270376 Stuttgart

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。