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

Exyte; Bad Homburg vor der Höhe; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

一家领先的工程公司在德国Hessen招募一名工程师，以负责GMP合规资格活动、供应商协调及跨职能沟通。适合有生物技术或药剂学背景的候选人，要求流利英语和较好德语沟通能力。提供良好的工作环境和灵活的工作方式。

Leistungen

两天的入职培训

灵活的工作方式

健身合同补贴

Qualifikationen

• 具备GMP和验证的相关法规技术知识。
• 在生命科学行业的实习经历优先考虑。
• 主动独立的工作风格，以及高度的质量意识和效率。

Aufgaben

• 处理GMP规定的具体资格和验证活动。
• 准备和审核资格和验证文档。
• 在实施阶段现场协调和独立进行资格验证。

Kenntnisse

生物技术相关知识

流利的英语书面和口语能力

优秀的德语技能

项目管理能力

Ausbildung

生物技术、药剂学或相关领域的学位

Jobbeschreibung

Overview

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 - Equipment and Process(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:

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。