Project Engineer Computer System Validation (m/f/d)

☞ Exyte

Ver: 214

Dia de atualização: 24-10-2024

Localização: Marburg an der Lahn Hesse

Categoria: Alta tecnologia Mecânico / Técnico Elétrica / Eletrônica IT - Software

Indústria: Civil Engineering

Posição: Entry level

Tipo de empregos: Full-time

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Conteúdo do emprego

Your vision is ambitious. Just like ours.

Our people are our success. As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community of challenge seekers who are ambitious and passionate about innovation. Together, we will build on our company’s long history and keep on leading the way to a better world.

A task that challenges
  • Performing CSV on the software of process equipment and building technologies in the pharmaceutical industry.
  • Preparation of system life cycle documents, such as validation/qualification plans, requirement specifications, risk analyses, test plans, etc.
  • Execution of GAP analyses with regard to pharmaceutical quality requirements
  • Support for new and further development of services
  • Customer consulting for the introduction of IT validation concepts
  • Support with GMP-specific audits, IT change management, test management
A background that convinces
  • Successfully completed technical degree or completed technical training with professional experience in the area of qualification/validation in the pharmaceutical industry.
  • Sound knowledge of qualification, validation, CSV and GMP documentation
  • Good knowledge of current European and American GMP regulations, especially Annex 11 and 21 CFR Part 11 and ISPE GAMP 5
  • Willingness to familiarize yourself with various software applications
  • Flexibility, willingness to travel and a high service orientation, as well as good language skills in German and English
An environment that inspires
  • Individual further development: Further training is very important at Exyte. We offer extensive internal and external training opportunities
  • Work-life balance: We offer you flexible working (time) models, e.g. flextime and part-time models. With the most modern work equipment you are mobile and can work from anywhere
  • Company pension: Our employees benefit from attractive framework conditions for your personal pension
  • Health & Sport: If you want, you can take part in a company run with the Exyte team or use one of the other sports or leisure activities. In addition, our company subsidizes your participation in the “Qualitrain” program, which allows you to take part in several fitness courses and sports
  • Good togetherness: At Exyte we always work together in intercultural teams and celebrate our successes together - whether it’s a summer party or a Christmas party
  • Attractive location: You can easily reach us by car or by S-Bahn and U-Bahn, which we subsidize with the job ticket. If you like to ride a bike, we would be happy to subsidize your e-bike
  • Catering is provided: coffee, tea, sofa corner and table football are available free of charge - two subsidized canteens and several restaurants can be found in the immediate vicinity
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Data limite: 08-12-2024

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