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- Aufgaben: Join us as a CSV Engineer and lead validation projects in a dynamic environment.
- Arbeitgeber: Capgemini Engineering Switzerland is all about innovation and excellence in a diverse workplace.
- Mitarbeitervorteile: Enjoy 30%-70% remote work, ergonomic home-office equipment, gym contributions, and a supportive culture.
- Warum dieser Job: Be part of a success story while growing professionally and personally in a fast-paced team.
- Gewünschte Qualifikationen: Bachelor/Master's in sciences, 4 years CSV experience, and pharma/biotech background required.
- Andere Informationen: Direct applications only; Swiss or EU/EFTA applicants preferred.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
At Capgemini Engineering Switzerland, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, providing training, tools, and foundations for your professional and personal growth. We are looking for an experienced CSV Engineer .
Responsibilities
- Assess and produce the CSV package(s) on an assigned project, taking accountability for the work to be produced.
- Plan, coordinate, and execute all phases for computer system validation of production and QC Lab systems including, but not limited to, validation plans, FMEA, RTM, DQ, IQ, OQ, and PQ test scripts.
- Prepare, review, and approve technical and GMP-related documentation (URS, impact/risk assessment, master plans, qualification/validation documentation).
- Understand customer needs and define electronic records requirements for computerized systems adhering to regulations and company standards.
- Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems.
- Validation planning for base business including interaction with IT, Maintenance Automation, and Quality Operations groups.
- Contribute to ensuring that changes introduced in the organization of systems, procedures, processes, and formulas are managed so that all aspects of the equipment/computerized systems commissioning and qualification process are assessed and resolved.
Your Profile
- Bachelor/Master’s Degree in technical or natural sciences.
- A minimum of 4 years of working experience with CSV.
- A minimum of 3 years of working experience within a pharma or biotech company.
- Know-how of CSV requirements according to FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
- Experience in defining strategy and validating computerized manufacturing equipment (CSV context).
- Analytical thinking and problem-solving ability.
- Ability to work under minimal supervision; assess priorities and work well under pressure in a fast-paced environment.
- Ability to effectively work as part of a multidisciplinary, international team.
We offer between 30% and 70% remote work in agreement with your manager and client needs (40% for cross-border due to tax regulations). Additional benefits include options to order ergonomically proven equipment for your home-office premises, support for training, contributions to gym subscriptions, a trust-based managerial culture, and team rituals and get-togethers.
We look forward to receiving your application. Capgemini Engineering only accepts direct applications (no recruitment agencies). Due to Swiss regulations, we only consider Swiss or EU/EFTA applicants or applicants with a valid work permit.
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CSV Engineer Arbeitgeber: TN Switzerland
Kontaktperson:
TN Switzerland HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: CSV Engineer
✨Tip Number 1
Make sure to familiarize yourself with the specific CSV regulations mentioned in the job description, such as FDA 21CFR part 11 and EUGMP Annex 11. This knowledge will not only help you during the interview but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Highlight your experience in planning and executing validation phases, especially in a pharma or biotech context. Be prepared to discuss specific projects where you successfully managed these processes, as this will showcase your hands-on expertise.
✨Tip Number 3
Since the role involves working in a multidisciplinary, international team, emphasize your ability to collaborate effectively across different functions. Share examples of how you've worked with IT, Quality Operations, or Maintenance Automation teams in the past.
✨Tip Number 4
Prepare to discuss your problem-solving skills and analytical thinking. Think of scenarios where you faced challenges in CSV and how you approached them, as this will illustrate your capability to work under pressure and prioritize tasks effectively.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: CSV Engineer
Tipps für deine Bewerbung 🫡
Understand the Job Requirements: Carefully read the job description for the CSV Engineer position at Capgemini Engineering. Make sure you understand the responsibilities and qualifications required, especially the specific CSV regulations and guidelines mentioned.
Tailor Your CV: Customize your CV to highlight your relevant experience in computer system validation, particularly within the pharma or biotech industry. Emphasize your familiarity with FDA 21CFR part 11 and EUGMP Annex 11 regulations.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your analytical thinking and problem-solving abilities. Mention specific projects where you successfully executed CSV processes and how you can contribute to Capgemini Engineering's success.
Highlight Teamwork Experience: Since the role requires working as part of a multidisciplinary, international team, be sure to include examples of your teamwork experience. Discuss how you effectively collaborated with different departments to achieve project goals.
Wie du dich auf ein Vorstellungsgespräch bei TN Switzerland vorbereitest
✨Understand the CSV Process
Make sure you have a solid grasp of the computer system validation (CSV) process, including all phases like DQ, IQ, OQ, and PQ. Be prepared to discuss your experience with these phases and how you've applied them in previous roles.
✨Familiarize Yourself with Regulations
Brush up on FDA 21CFR part 11 and EUGMP Annex 11 regulations, as well as ISPE GAMP 5 guidelines. Being able to articulate how these regulations impact your work will demonstrate your expertise and commitment to compliance.
✨Showcase Your Problem-Solving Skills
Prepare examples that highlight your analytical thinking and problem-solving abilities. Discuss specific challenges you've faced in CSV projects and how you overcame them, especially in a fast-paced environment.
✨Emphasize Team Collaboration
Since the role involves working within a multidisciplinary, international team, be ready to share experiences where you successfully collaborated with others. Highlight your ability to communicate effectively and adapt to different working styles.
