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- Aufgaben: Ensure compliance with pharma standards and lead CSV activities for IT systems.
- Arbeitgeber: Join a leading biopharmaceutical company known for innovation and impact.
- Mitarbeitervorteile: Collaborative environment, professional growth opportunities, and impactful projects.
- Warum dieser Job: Work on projects that directly support patient outcomes in a dynamic team.
- Gewünschte Qualifikationen: Bachelor’s degree and 7-10 years in pharma/biotech; fluent in English and French.
- Andere Informationen: Contractor role for 4-6 months; Swiss residency or work permit required.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
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 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)
Your tasks:
- 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: gloor&lang AG
Kontaktperson:
gloor&lang AG 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 regulatory frameworks in your conversations. This is crucial for the role, and demonstrating your expertise can set you apart from other candidates.
✨Tip Number 2
Since this position requires strong communication skills in both English and French, practice discussing your previous projects in both languages. Being able to articulate your experience fluently will show your capability to work in a multilingual environment.
✨Tip Number 3
Familiarize yourself with the specific IT systems mentioned in the job description, such as MES and SAP. Having a solid understanding of these systems will allow you to engage more effectively during interviews and demonstrate your readiness for the role.
✨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 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and qualifications required for the CSV and IT Compliance Engineer/Manager position. Tailor your application to highlight relevant experiences.
Highlight Relevant Experience: Emphasize your 7-10 years of experience in the pharmaceutical or biotechnology industry, particularly focusing on your expertise in Computer System Validation (CSV) and Quality Management Systems. Use specific examples to demonstrate your skills.
Showcase Language Proficiency: Since proficiency in both English and French is mandatory, make sure to clearly indicate your language skills in your CV and cover letter. If applicable, provide examples of how you've used these languages in a professional context.
Tailor Your Documents: Customize your CV and cover letter to reflect the specific requirements mentioned in the job description, such as knowledge of regulatory frameworks and experience with IT systems like MES and SAP. This will show that you are a strong fit for the role.
Wie du dich auf ein Vorstellungsgespräch bei gloor&lang AG vorbereitest
✨Showcase Your Technical Expertise
Make sure to highlight your experience with Computer System Validation (CSV) and your knowledge of regulatory frameworks like 21-CFR Part 11 and EudraLex. Be prepared to discuss specific projects where you successfully implemented these standards.
✨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 relation to quality management systems and IT compliance.
✨Emphasize Communication and Collaboration
Since the role involves working in multidisciplinary, international teams, be ready to share experiences where your communication skills made a difference. Highlight any instances where you facilitated collaboration between different departments or teams.
✨Be Ready for Technical Questions in French
As this position requires fluency in French, practice discussing technical topics in both English and French. This will demonstrate your language proficiency and ensure you're comfortable communicating complex ideas in either language.
