Engineer Cleanroom Qualification (m/f/d) at Exyte GmbH

Nuremberg, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

18 Apr, 26

Salary

0.0

Posted On

18 Jan, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Qualification, Validation, GMP Regulations, Risk Analysis, Test Protocols, Supplier Coordination, Communication, Project Management, Biotechnology, Pharmaceutical Engineering, Process Engineering, Medical Devices, Data Integrity, ISO Standards, Cleanroom Systems, HVAC Systems

Industry

Construction

Description

Description 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 katharina.hermann@exyte.net 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.

Responsibilities

You will be responsible for project-specific qualification and validation activities according to GMP regulations. This includes preparing and reviewing qualification documents and coordinating supplier communications.