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- Aufgaben: Lead validation strategies and ensure compliance in the pharmaceutical sector.
- Arbeitgeber: B-HIVE is a rapidly growing engineering firm with over 900 employees globally.
- Mitarbeitervorteile: Join a dynamic team with opportunities for professional growth and development.
- Warum dieser Job: Make an impact in a thriving industry while working with cutting-edge technologies.
- Gewünschte Qualifikationen: Engineering degree and experience in computer system validation required.
- Andere Informationen: Open to Swiss or EU/EFTA nationals, or those with valid Swiss work permits.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Talent Acquisition Specialist B-Hive AG – Chemical Engineer
Founded in 2017, B-HIVE is an engineering company that has experienced continuous and significant growth, currently employing over 900 people worldwide.
As part of the development of our activities in Switzerland, we are recruiting a CSV Expert who will be responsible for:
- Defining the validation strategy and developing a clear approach to validate the system in compliance with regulations (GxP, FDA 21 CFR Part 11, EU Annex 11, etc.).
- Planning validation activities while considering project-specific risks and needs.
- Writing key validation documents, including the Validation Master Plan, URS, protocols and the traceability matrix.
- Providing support and expertise to meet validation requirements.
- Identifying and documenting risks related to data compliance.
Required Profile:
- Engineering degree with proven experience in computer system validation within the pharmaceutical industry.
- Familiarity with OWL, W3C standards, GMP, and 21 CFR Part 11.
- Technical knowledge of tools such as AWS, LIMS, MES, and SAP.
- Languages: Professional proficiency in English.
Only applicants with Swiss or EU / EFTA nationality, or those holding a valid Swiss work and residency permit, will be considered.
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Ingénieur Workplace Arbeitgeber: Ansam Group
Kontaktperson:
Ansam Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Ingénieur Workplace
✨Tip Number 1
Make sure to network with professionals in the pharmaceutical industry, especially those who have experience in computer system validation. Attend industry conferences or webinars where you can meet potential colleagues and learn more about the latest trends and requirements.
✨Tip Number 2
Familiarize yourself with the specific regulations mentioned in the job description, such as GxP and FDA 21 CFR Part 11. Being able to discuss these regulations confidently during an interview will demonstrate your expertise and commitment to compliance.
✨Tip Number 3
Consider obtaining certifications related to computer system validation or quality assurance in the pharmaceutical sector. This can enhance your credibility and show that you are serious about your professional development.
✨Tip Number 4
Prepare to discuss specific projects where you have successfully implemented validation strategies. Be ready to share examples of how you identified risks and ensured compliance, as this will highlight your practical experience and problem-solving skills.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Ingénieur Workplace
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Ingénieur Workplace position at B-Hive AG. Understand the key responsibilities and required qualifications, especially regarding computer system validation in the pharmaceutical industry.
Tailor Your CV: Customize your CV to highlight relevant experience in computer system validation, particularly within the pharmaceutical sector. Emphasize your familiarity with regulations like GxP and FDA 21 CFR Part 11, as well as any technical knowledge of tools such as AWS, LIMS, MES, and SAP.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background and skills to the specific requirements of the role. Mention your engineering degree and any relevant projects or experiences that demonstrate your expertise in validation strategies and compliance.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is clear, concise, and professional, reflecting your attention to detail, which is crucial for this role.
Wie du dich auf ein Vorstellungsgespräch bei Ansam Group vorbereitest
✨Understand the Regulations
Make sure you have a solid grasp of GxP, FDA 21 CFR Part 11, and EU Annex 11. Be prepared to discuss how these regulations impact your approach to validation in the pharmaceutical industry.
✨Showcase Your Technical Skills
Highlight your experience with tools like AWS, LIMS, MES, and SAP during the interview. Be ready to provide specific examples of how you've used these tools in past projects.
✨Prepare Key Validation Documents
Familiarize yourself with key validation documents such as the Validation Master Plan, URS, and protocols. You might be asked about your experience writing or reviewing these documents.
✨Discuss Risk Management
Be prepared to talk about how you identify and document risks related to data compliance. Share examples of how you've managed project-specific risks in previous roles.
