Lead Engineer Qualification (m/f/d)

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 Lead Engineer Qualification (m/f/d), you work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification & Validation.  You can work in a team of highly qualified and experienced engineers from different regional departments like Stuttgart - Nürnberg - Penzberg - Leverkusen 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

  • 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 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 Qualitrain at over 5,000 locations in German


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