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- Aufgaben: Support biotech process equipment and write validation plans.
- Arbeitgeber: Join GXP CONSULTING, a passionate Swiss company in Life Sciences since 2014.
- Mitarbeitervorteile: Enjoy open communication, team spirit, and continuous learning opportunities.
- Warum dieser Job: Make a real impact in biotech while collaborating with industry leaders.
- Gewünschte Qualifikationen: Master’s degree and 5 years of experience in equipment qualification required.
- Andere Informationen: Fluency in French and English is essential; German is a plus.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle in the following areas:
R&D, Engineering, Quality Assurance, Qualification/Validation, Regulatory Affairs, Operational Excellence, Manufacturing, Maintenance, and Project Management.
About the job:
- Support for Biotech Process equipment (USP, DSP, Media Prep, Buffer Prep, inoculum, washing machine, autoclave, warehouse)
- Writing of validation plans and validation summary reports
- Review and customization of suppliers’ protocols and reports (IQ, OQ, PQ)
- Co-ordinate qualification execution activities, including external vendors, internal departments, organizing materials, etc.
- Manage associated qualification deviations & CAPAs, including opening, resolution (with Supplier) and closure
- Participate in the creation and review of process Risk Assessments
About you:
- You hold a Master’s in scientific or engineering discipline
- You possess a minimum of 5 years of experience in equipment qualification (IQ, OQ, PQ) with at least the last 3 years in the biotech sector
- Experience in biotechnology sector mandatory
- You possess an experience in USP and / or DSP
- You are competent with current FDA and EU regulations and best practices
- You are familiar with GAMP
- You are fluent in French and English. Fluent in German is a big plus
About us:
- Human-sized company with colleagues from diverse cultural and professional backgrounds
- Open communication
- Joint team spirit
- Continuous learning and development thanks to internal trainings and workshops
At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you!
By Mail
Voie du chariot 3
1003 Lausanne
Switzerland
PO BOX 8009
#J-18808-Ljbffr
Qualification Validation Engineer Biotech Arbeitgeber: Gxp Consulting Switzerland
Kontaktperson:
Gxp Consulting Switzerland HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Qualification Validation Engineer Biotech
✨Tip Number 1
Make sure to highlight your experience in equipment qualification, especially in the biotech sector. Use specific examples from your past roles to demonstrate your expertise in IQ, OQ, and PQ processes.
✨Tip Number 2
Familiarize yourself with the latest FDA and EU regulations as well as GAMP guidelines. Being able to discuss these topics confidently during your interview will show that you are well-prepared and knowledgeable.
✨Tip Number 3
Since the role requires fluency in French and English, practice discussing technical concepts in both languages. This will help you communicate effectively with the team and demonstrate your language skills.
✨Tip Number 4
Research GXP Consulting Switzerland's company culture and values. Be ready to share how your personal values align with theirs, emphasizing your commitment to teamwork and continuous learning.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Qualification Validation Engineer Biotech
Tipps für deine Bewerbung 🫡
Understand the Company Culture: Before applying, take some time to understand GXP Consulting Switzerland's values and culture. Highlight how your personal values align with their focus on placing humans at the heart of their operations.
Tailor Your CV: Make sure your CV reflects your experience in equipment qualification, particularly in the biotech sector. Emphasize your knowledge of FDA and EU regulations, as well as your familiarity with GAMP.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific experiences that demonstrate your expertise in USP and DSP processes, and how you can contribute to their team.
Highlight Language Proficiency: Since fluency in French and English is required, make sure to clearly state your language skills in your application. If you have proficiency in German, mention that as a bonus.
Wie du dich auf ein Vorstellungsgespräch bei Gxp Consulting Switzerland vorbereitest
✨Show Your Passion for Biotech
Make sure to express your enthusiasm for the biotech industry during the interview. Share specific examples of how your experience aligns with the company's mission of placing humans at the heart of its DNA.
✨Demonstrate Your Technical Expertise
Be prepared to discuss your experience with equipment qualification (IQ, OQ, PQ) in detail. Highlight your familiarity with USP and DSP processes, as well as your understanding of current FDA and EU regulations.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills, especially regarding qualification deviations and CAPAs. Think of past experiences where you successfully managed similar challenges and be ready to share those stories.
✨Emphasize Your Collaborative Spirit
Since GXP Consulting values teamwork, be sure to highlight your ability to work collaboratively with diverse teams. Discuss any previous experiences where you coordinated with external vendors or internal departments to achieve a common goal.
