Senior CSV Consultant Full-time (m/f)

Engineering|Allschwil

Exyte is a world leader in the design, development and supply of equipment for the high-tech industry. Since its founding more than 100 years ago, Exyte has developed unique expertise in controlled and regulated manufacturing environments. The company operates around the world, working with the most technically demanding customers in markets such as semiconductors, batteries, biotech, pharmaceuticals and data centers. Exyte offers its customers a full range of services, from consulting to turnkey solutions management, while maintaining the highest standards of quality and safety. The company values trusting, long-lasting relationships with its customers and supports them in overcoming complex challenges. In 2020, Exyte generated sales of EUR 4.1 billion with around 4,900 highly motivated and experienced employees. With its extensive industry know-how and exceptional employees, the company is ideally positioned to further expand its leading market position. www.exyte.net

Your vision is ambitious. Just like ours.

Our employees are our success. As one of us, you'll contribute to technical 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 challengers who are ambitious and passionate about innovation. Together, we will build on our company's long history and continue to lead the way to a better world.

A role that challenges

• Lead and execute software validation and infrastructure qualification projects in the regulated life sciences environment.


• Consulting, coaching and developing IT quality management concepts.


• Introduction of CSV concepts into existing quality management systems (CSV policies, SOPs, validation master plans, etc.).


• Conducting workshops, CAP assessments and IT compliance audits.


• Implementation and execution of CAPA plans.


• Independently prepare life cycle validation and qualification documents for computerized or automated systems.


• Validation and qualification of IT infrastructure and IT services.


• Active support in the acquisition of customer projects.


• Willingness for own professional development and active participation in the own professional development of the department with regard to changes in legislation, new technologies and the range of services.

A background that convinces

• Completed academic education in the field of natural sciences or engineering (computer science, automation technology, engineering, pharmaceutical technology or in a comparable field).


• Practical experience (min. 5 years) in the field of computer system validation and IT infrastructure qualification in the life science industry.


• Sound knowledge of the underlying requirements (EU-GMP Guideline, 21 CFR Part 11/210/820, ISO13485, MDR etc.).


• Initiative, reliability, willingness to travel and a high level of service orientation, as well as fluent written and spoken German and English.

An environment that inspires

• Work-life balance: We offer you flexible working (time) models, e.g. flexitime and part-time models. Thanks to state-of-the-art work equipment, you are mobile and can work from anywhere.


• Individual further development: Exyte attaches great importance to further training. We offer comprehensive internal and external training opportunities


• Company pension scheme: Our employees benefit from attractive conditions for their personal pension scheme.


• Health & Sports: If you want, you can join the Exyte team at the start of a company run or take advantage of one of our other sports or leisure activities.


• Good cooperation: At Exyte we always work together in intercultural teams and celebrate our successes together - no matter if summer party, Christmas party or winter event.


• Attractive location: You can reach us easily by car, bus or bicycle.


• Catering is provided: coffee, tea and water are available free of charge - in the immediate vicinity you will find a canteen, various restaurants and a petrol station shop.

Important to know

• Start date: by arrangement


• Workload: full-time or part-time by arrangement


• Place of work: Basel or Schlieren

Your contact

Would you like to become part of the Exyte team? Then we are looking forward to your application!
Applications by mail or e-mail will not be processed. Please apply via our homepage www.exyte.net
.

If you have any
questions or require further information, please do not hesitate to contact us by phone +41 486 98 15
.

Exyte
Central Europe GmbH Ramona
Schindler HR
Business Partner Gewerbestrasse
12 4123
Allschwil

Our people are the corner stone of our success, and I believe one of the most important investments we can make is to care for their well-being.

Dr. Wolfgang Büchele, CEO Exyte

Get more than just a job

• Engineer World Changing Facilities




• Health & Well-being




• Environment of Excellence




• Career Growth




• Commitment to an Incident-Free Workplace (IFW)




• Global Opportunities

Equal employment opportunity

Exyte Group is an equal employment opportunity employer. Exyte Group provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

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