CSV Expert (w/m/d)
Welcome to our sector Life Sciences. Around 3,000 colleagues worldwide make their contribution to the most important thing in life: health. From the development of vaccines and the digitalisation of the health care system to forward-looking topics such as eHealth and digital therapeutics, we place our expertise in the pharmaceutical sector, medical technology and biotechnology at the service of our renowned customers. Are you the one to explore LIFE?
YOUR TASKS AND RESPONSIBILITIES WITH US
- You are responsible for the preparation, follow-up and implementation of computer system validation on GxP-relevant systems (e.g. document or quality management systems) in the pharmaceutical industry.
- You prepare as well as review and approve validation documents for computerised systems, e.g. validation and qualification plans, specifications, risk analyses, deviation reports, IQ/OQ/PQ.
- You carry out GAP analyses regarding quality requirements within the pharmaceutical standards.
- You advise the departments on the acquisition of software and computer-controlled systems.
- You support in GxP audits, IT change management, test management.
- You supervise the life cycle of the validated computerised systems (in cooperation with the departments).
- You contribute to the continuous improvement of internal specifications and processes for computerised system validation.
YOU CONVINCE US WITH
- Bachelor's degree or equivalent in a scientific, Engineering, IT discipline or related field.
- A minimum of 3 years computerized system validation related experience in a cGMP pharmaceutical, biotechnology and / or biomedical industry.
- Working knowledge of lab equipment / instrumentation, test methodologies, process, and facility validation in a regulated environment.
- Profound knowledge of GMP and in particular of qualification and validation.
- Good knowledge in the application of the EU GMP guidelines, in particular GAMP 5.
- Ability to work in multinational teams and collaborate with our clients at enterprise level.
- Strong analytical thinking, above-average comprehension skills, independent problem-solving ability.
- Reliability, strong communication skills and strong team play.
- Business fluent in English and very good presentation and communication skills, German skills are a plus.
- Willingness to travel within Germany.
Not a 100% match? No need to worry! Capgemini Engineering supports you with a wide range of learning opportunities so that you can develop both professionally and personally.
WE LOOK FORWARD TO MEETING YOU
Do you have any questions about the job profile and/or requirements?
Please get in touch with your contact person in Recruiting.
Capgemini Engineering
Altran Deutschland S.A.S. & Co. KG
Asaja Köppermann
+49 1748349917
[email protected]
Please fill in our online application form completely and attach your CV. We wish you every success for your application.
Capgemini Engineering is committed to the employment of a diverse workforce. Qualified applicants are considered regardless of their origin, skin colour, religion, gender, age, sexual orientation, gender identity, gender expression, veteran status or disability.
Great Place to Work
Individueller Karriereplan
Vielfältiges Weiterbildungsangebot
Industrieübergreifender Wissenstransfer
E-Gym WellPass
Nachhaltig unterwegs - Das JobRad-Programm
Einkaufsvorteile und Rabattaktionen
Zahlreiche Events
Attraktives Mitarbeiterbeteiligungsprogramm
Betriebliche Altersvorsorge
Mobiles Arbeiten nach Absprache
Individuelle Arbeits- und Teilzeitmodelle
Wertorientierte Unternehmenskultur
Individual career plan
Diverse range of further trainings
Cross-industry knowledge transfer
E-Gym WellPass
Sustainable on the road - the JobRad program
Shopping advantages and discount promotions
Numerous events
Attractive employee stock ownership program
Company pension plan
Mobile work by arrangements
Individual work and part-time models
Value oriented corporate culture
Work with great people
About the company
Since 2020, Capgemini Engineering (formerly Altran) has been an integral part of Capgemini, a global leader in consulting, digital transformation, technology and engineering services. As a part of the Capgemini family and a global leader in engineering and R&D services, we bring the most powerful innovation for Intelligent Industry to the world of tomorrow: on the road, in the air, on the seas, in rail transport, in energy production, in life science, finance and telecommunications. We have more than 52,000 engineers and scientists in over 30 countries. Our mission to develop technology for an inclusive and sustainable future requires one thing above all: human energy! We want to grow. Are you a technology enthusiast, ambitious and would you like to be a part of something big? Are you the ONE for Capgemini Engineering?
-Unser Bewerbungsprozess
Deine BewerbungBewirb dich jetzt online und werde ein Teil unserer globalen und diversen Community und arbeite Seite an Seite mit deinem Team, an einer nachhaltigen und integrativen Zukunft.
Wir melden uns bei dir!Nachdem wir deine Unterlagen gesichtet haben, melden wir uns schnellstmöglich bei dir.
Persönliches KennenlernenIn einem persönlichen Gespräch wollen wir mit dir ins Gespräch kommen, um uns gegenseitig näher kennenzulernen.
Unser Angebot an dichNach einem erfolgreichen Bewerbungsprozess senden wir dir dein attraktives Vertragsangebot.
Willkommen im Team!Im Rahmen unserer Onboarding-Veranstaltung heißen wir dich herzlich willkommen, knüpfen gemeinsam erste wichtige Kontakte und stellen dir unsere Unternehmenskultur vor.
-OUR APPLICATION PROCESS
Your applicationApply online now to become a part of our global and diverse community and work side by side with your team, towards a sustainable and inclusive future.
We'll get back to you!After we have reviewed your documents, we will contact you as soon as possible.
Get to know each otherIn a personal conversation we want to get in touch with you to get to know each other better.
Our offer to youAfter a successful application process, we will send you your attractive contract offer.
Welcome to our team!As part of our onboarding event, we will give you a warm welcome, establish important initial contacts together and introduce you to our corporate culture.
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