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- Aufgaben: Lead Computer System Validation activities and ensure compliance with industry standards.
- Arbeitgeber: Join a globally recognized biopharmaceutical leader focused on innovation and patient outcomes.
- Mitarbeitervorteile: Collaborative work environment with opportunities for professional growth and impactful projects.
- Warum dieser Job: Be part of a dynamic team making a real difference in the pharmaceutical industry.
- Gewünschte Qualifikationen: Bachelor’s degree and 7-10 years in pharma/biotech, fluent in English and French.
- Andere Informationen: Contract position for 4-6 months; Swiss residency or valid work permit required.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
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CSV and IT Compliance Engineer/Manager, Neuchâtel
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Location:
Job Category:
Other
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Job Reference:
ee53f9d91315
Job Views:
7
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
4-6 months contractor – FRENCH Speaking necessary
Our customer is an innovative biopharmaceutical Big Pharma company. For an on-site assignment for the brand new commercial manufacturing site, we are looking for 2 experts in CSV for the Pharma Industry.
As part of their continuous growth, our client is implementing new IT systems at their local manufacturing and packaging units. To support these initiatives, we are seeking an experienced CSV and IT Compliance Engineer/Manager.
You have:
- Bachelor’s degree in Science, Engineering, or a related discipline.
- 7-10 years of experience in the pharmaceutical or biotechnology industry, including expertise in Quality Management Systems and GxP systems such as MES and SAP.
- Proficiency in Computer System Validation (CSV), Data Integrity requirements, and regulatory frameworks (21-CFR Part 11, EudraLex, MHRA).
- Experience with Six Sigma, Lean, or Business Process Change techniques is a plus.
- Strong analytical and structured working style with exceptional attention to detail.
- Excellent communication and collaboration skills to work in multidisciplinary, international teams.
- Fully operational in both English and French.
- Swiss residency or a valid Swiss work permit is mandatory (cross-border candidates welcome).
- Ensure compliance with pharmaceutical industry standards and regulations, including EU-GMP Annex 11 and 21-CFR part 11.
- Lead Computer System Validation (CSV) activities for site IT systems and infrastructure.
- Act as the local representative for global IT projects with quality implications, such as Digital Modernization initiatives.
- Oversee the qualification of site IT infrastructure in collaboration with global teams.
- Define quality expectations and support the IT department and third parties in implementing GMP-compliant systems.
- Conduct risk-based prioritization of IT activities in support of Quality Assurance.
- Translate compliance requirements into test conditions and acceptance criteria for application functionality (IQ, PQ, FAT).
- Ensure adherence to design and governance standards while contributing to effective communication with stakeholders.
You will:
- Be part of an innovative, dynamic team at a globally recognized biopharmaceutical leader.
- Work on impactful projects that directly support patient outcomes.
- Enjoy a collaborative work environment with opportunities for professional growth.
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CSV and IT Compliance Engineer/Manager Arbeitgeber: TN Switzerland
Kontaktperson:
TN Switzerland HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: CSV and IT Compliance Engineer/Manager
✨Tip Number 1
Make sure to highlight your experience with Computer System Validation (CSV) and your familiarity with regulatory frameworks like 21-CFR Part 11. This is crucial for the role, so be ready to discuss specific projects where you applied these skills.
✨Tip Number 2
Since the position requires strong communication skills in both English and French, practice discussing your technical expertise in both languages. This will help you demonstrate your bilingual capabilities during interviews.
✨Tip Number 3
Familiarize yourself with the company's recent initiatives in digital modernization and IT compliance. Showing that you understand their current projects can set you apart as a candidate who is genuinely interested in contributing to their goals.
✨Tip Number 4
Network with professionals in the biopharmaceutical industry, especially those who have experience in CSV and IT compliance. Engaging with industry peers can provide valuable insights and potentially lead to referrals for the position.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: CSV and IT Compliance Engineer/Manager
Tipps für deine Bewerbung 🫡
Highlight Relevant Experience: Make sure to emphasize your 7-10 years of experience in the pharmaceutical or biotechnology industry. Detail your expertise in Computer System Validation (CSV) and Quality Management Systems, as these are crucial for the role.
Showcase Language Proficiency: Since the position requires proficiency in both English and French, include examples of your language skills in your CV and cover letter. Mention any relevant experiences where you used these languages in a professional setting.
Detail Your Technical Skills: Clearly outline your knowledge of regulatory frameworks such as 21-CFR Part 11 and EudraLex. Discuss your familiarity with IT systems like MES and SAP, as well as methodologies like Six Sigma or Lean, to demonstrate your technical capabilities.
Tailor Your Application: Customize your CV and cover letter to reflect the specific requirements mentioned in the job description. Use keywords from the listing to ensure your application aligns with what the company is looking for.
Wie du dich auf ein Vorstellungsgespräch bei TN Switzerland vorbereitest
✨Showcase Your Technical Expertise
Make sure to highlight your experience with Computer System Validation (CSV) and your familiarity with regulatory frameworks like 21-CFR Part 11. Be prepared to discuss specific projects where you successfully implemented these systems.
✨Demonstrate Your Problem-Solving Skills
Prepare examples that showcase your analytical abilities and structured working style. Discuss how you've approached challenges in the past, particularly in the context of quality management systems or IT compliance.
✨Communicate Effectively in Both Languages
Since the role requires proficiency in both English and French, practice discussing your experiences and technical knowledge in both languages. This will demonstrate your ability to communicate with diverse teams.
✨Understand the Company’s Culture and Values
Research the biopharmaceutical company and understand its mission and values. Be ready to explain how your personal values align with theirs and how you can contribute to their innovative and collaborative environment.
