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- Aufgaben: Lead validation of computerized systems in a dynamic, agile environment.
- Arbeitgeber: Join Lonza, a global leader in life sciences making a real impact.
- Mitarbeitervorteile: Enjoy a collaborative culture with opportunities for growth and development.
- Warum dieser Job: Be part of innovative projects that enhance processes and help people worldwide.
- Gewünschte Qualifikationen: University degree in relevant fields and extensive CSV experience required.
- Andere Informationen: Fluency in English is essential; German skills are a plus.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. And that’s the kind of work we want to be part of.
As a Senior CSV Engineer, Biologics (m/f/d) you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities, including MES. You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as contribute to the ongoing optimization of processes, facilities and internal procedures.
An agile dynamic working culture
Preparation of commissioning and validation documents for new systems, as well as the supervision of conversion, expansion and new construction projects. This is broken down into CSV activities on new construction projects for critical systems and SLC support for all systems after going live.
Supervising the junior CSV Engineers including training and coaching.
University degree in Computer Sciences/Life Sciences/Engineering or similar relevant experience.
Profound experience with CSV preferably in a CQV-CSV environment, Regulatory Compliance, Project and Lifecycle Management, Quality Assurance and Risk Management, Deviation/CAPA and Change Control.
Quality Assurance and Validation experience with FDA and EU regulations.
Certified Quality Engineer (CQE), Certified Pharmaceutical Industry Professional (CPIP), GAMP 5 Certification, Certified Quality Auditor (CQA), Certified Quality Management System (CQMS), Project Management Professional (PMP), Certified Information Systems Auditor (CISA), Certified Data Integrity Professional (CDIP), or similar.
Fluency in English is required, and German language skills are an advantage.
Senior Engineer - Quality Arbeitgeber: Lonza
Kontaktperson:
Lonza HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Engineer - Quality
✨Tip Number 1
Familiarize yourself with the specific regulations and standards related to CSV in the life sciences sector. Understanding FDA and EU regulations will not only enhance your knowledge but also demonstrate your commitment to quality assurance during the interview.
✨Tip Number 2
Highlight your experience with project management and lifecycle management in your discussions. Be prepared to share examples of how you've successfully managed CSV activities in previous roles, as this will showcase your ability to handle the responsibilities of the Senior Engineer position.
✨Tip Number 3
If you have certifications like CQE or PMP, make sure to mention them during your conversations. These credentials can set you apart from other candidates and show that you have a solid foundation in quality engineering and project management.
✨Tip Number 4
Since the role involves supervising junior engineers, be ready to discuss your leadership style and any mentoring experiences you have. This will help us see how you can contribute to our team culture and support the development of others.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Engineer - Quality
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Engineer - Quality position. Understand the key responsibilities and required qualifications, especially focusing on CSV activities and regulatory compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with Computer System Validation (CSV) and any relevant certifications you hold. Mention specific projects where you have applied your skills in a CQV-CSV environment.
Showcase Your Skills: Demonstrate your knowledge of FDA and EU regulations in your application. Include examples of how you've contributed to quality assurance and risk management in previous roles.
Tailor Your Application: Customize your cover letter to reflect your passion for working in life sciences and your ability to work in an agile dynamic culture. Mention your fluency in English and any German language skills to stand out.
Wie du dich auf ein Vorstellungsgespräch bei Lonza vorbereitest
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with computerized systems validation (CSV) in detail. Highlight specific projects where you successfully implemented CSV activities, especially in a CQV-CSV environment, and how you ensured compliance with FDA and EU regulations.
✨Demonstrate Leadership Skills
Since the role involves supervising junior engineers, share examples of how you've trained or coached team members in the past. Discuss your approach to leadership and how you foster a collaborative working environment.
✨Emphasize Problem-Solving Abilities
Prepare to discuss challenges you've faced in project and lifecycle management, particularly related to quality assurance and risk management. Explain how you identified issues, implemented solutions, and what the outcomes were.
✨Communicate Effectively
Fluency in English is essential, so practice articulating your thoughts clearly and concisely. If you have German language skills, mention them as an advantage, and be ready to demonstrate your ability to communicate in both languages if necessary.
