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- Aufgaben: Lead Computer System Validation activities and ensure compliance with industry standards.
- Arbeitgeber: Join an innovative biopharmaceutical leader making a difference in patient outcomes.
- Mitarbeitervorteile: Collaborative work environment with opportunities for professional growth and impactful projects.
- Warum dieser Job: Be part of a dynamic team and contribute to meaningful projects in the pharma industry.
- Gewünschte Qualifikationen: Bachelor’s degree and 7-10 years experience in pharma, with expertise in CSV and regulatory frameworks.
- Andere Informationen: FRENCH speaking required; Swiss residency or valid work permit mandatory.
Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.
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CSV and IT Compliance Engineer/Manager, Yverdon-les-Bains
Client:
Location:
Job Category:
Other
Job Reference:
8d92ecf7598f
Job Views:
6
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 in 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've 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 involved in CSV and IT compliance. Engaging with them can provide insights into the company culture and may even 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 🫡
Understand the Role: Make sure to thoroughly read the job description for the CSV and IT Compliance Engineer/Manager position. Highlight the key responsibilities and required qualifications, and think about how your experience aligns with these.
Tailor Your CV: Customize your CV to emphasize your relevant experience in the pharmaceutical or biotechnology industry, particularly focusing on your expertise in Computer System Validation (CSV) and Quality Management Systems. Use specific examples that demonstrate your skills in GxP systems and regulatory frameworks.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Mention your proficiency in both English and French, as well as your ability to work in multidisciplinary teams.
Proofread Your Application: Before submitting your application, carefully proofread all documents to ensure there are no spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for this role.
Wie du dich auf ein Vorstellungsgespräch bei TN Switzerland vorbereitest
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with Computer System Validation (CSV) and regulatory frameworks like 21-CFR Part 11. Highlight specific projects where you ensured compliance and how you approached challenges in the pharmaceutical industry.
✨Demonstrate Your Analytical Skills
Since the role requires a strong analytical and structured working style, be ready to provide examples of how you've used these skills in past roles. Discuss any methodologies like Six Sigma or Lean that you've applied to improve processes.
✨Communicate Effectively in Both Languages
As the position requires proficiency in both English and French, practice discussing your experiences in both languages. This will not only demonstrate your language skills but also your ability to communicate complex ideas clearly to diverse teams.
✨Understand the Company’s Compliance Culture
Research the biopharmaceutical company’s approach to compliance and quality management. Be ready to discuss how you can contribute to their initiatives, especially regarding Digital Modernization and adherence to EU-GMP standards.
