Lead Engineer CSV (m/f/d)

TN Germany; Stuttgart; Vor Ort; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Consultant in Computer System Validation to join their dynamic team in Stuttgart. This role involves managing and implementing software validation projects in the life sciences sector, ensuring compliance with stringent regulations. You will have the opportunity to work on innovative projects across Germany and Europe, providing consulting and coaching to enhance IT quality management systems. The company offers a supportive environment with a focus on work-life balance, professional growth, and an attractive office space. If you are passionate about engineering excellence and eager to make an impact, this is the perfect opportunity for you.

Leistungen

Free coffee specialties

Water dispensers

Fitness contract subsidy

Mobile working options

Buddy-System for onboarding

Qualifikationen

• Academic training in natural sciences or engineering is essential.
• Experience in computer system validation in the life science industry is required.

Aufgaben

• Manage software validation and infrastructure qualification projects.
• Consult and develop IT quality management concepts.

Kenntnisse

Computer System Validation

IT Infrastructure Qualification

Quality Management Concepts

Workshop Facilitation

GAP Assessments

IT Compliance Audits

Fluent in German

Fluent in English

Ausbildung

Degree in Natural Sciences

Degree in Engineering

Tools

Validation Master Plans

SOPs

Jobbeschreibung

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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.

Discover your exciting role

As Senior Consultant CSV - Computer System Validation (m/f/d) you work in the Bio Life Science Sector at Exyte and in top projects on-site with our clients in the department Commissioning, Qualification & Validation - throughout Germany and Europe.

Explore your tasks and responsibilities

1. Management and implementation of software validation and infrastructure qualification projects in the regulated life science environment.
2. Consulting, coaching and development of IT quality management concepts.
3. Introduction of CSV concepts into existing quality management systems (CSV policies, SOPs, validation master plans, etc.).
4. Conducting workshops, GAP assessments and IT compliance audits as well as implementing and processing of CAPA plans.
5. Independent creation of life cycle validation and qualification documents for computer-aided or automated systems.
6. Validation and qualification of IT infrastructure and IT services as well as support in the acquisition of customer projects.

Show your expertise

1. Completed academic training in natural sciences or engineering (computer science, automation technology, engineering, pharmaceutical technology or in a comparable field of study).
2. Several years of work experience in the field of computer system validation and IT infrastructure qualification in the life science industry.
3. In-depth knowledge of the underlying requirements (EU-GMP guidelines, 21 CFR Part 11/210/820, ISO13485, MDR etc.).
4. Willingness to familiarize yourself with various software applications.
5. Flexibility, willingness to travel in German-speaking countries and a high level of service orientation.
6. Fluent use of both German and English is required.

What we offer you

1. Your start at Exyte: Take part in a two-day onboarding event with new colleagues.
2. Attractive location: Our location in Stuttgart features spacious workstations with height-adjustable desks.
3. Buddy-System: Several weeks of close familiarisation with your colleagues in the team.
4. Work-life balance: There is always the possibility of switching to mobile working.
5. Catering: Free coffee specialities as well as water dispensers are accessible on every floor.
6. Keep fit: Exyte subsidises your fitness contract through Qualitrain at over 5,000 locations in Germany.

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Contact

Exyte is an Equal Employment Opportunity employer and is committed to equal opportunity and equal treatment. Therefore, Exyte Group provides equal employment opportunities to all qualified applicants regardless of ancestry, gender, sexual orientation, gender identity, race, color, religion, protected veteran or disability status, or genetic information.

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