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- Aufgaben: Join us as a CSV Engineer and support exciting pharmaceutical projects in Switzerland!
- Arbeitgeber: Work with a global leader in active pharmaceutical ingredients and biotechnology.
- Mitarbeitervorteile: Enjoy a 12-month contract with opportunities for growth and collaboration.
- Warum dieser Job: Be a key player in ensuring compliance and quality in innovative pharmaceutical processes.
- GewĂĽnschte Qualifikationen: Bring your engineering degree and 5+ years of experience in CSV and project management.
- Andere Informationen: Fluency in English and German is essential; remote work options may be available.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CSV Engineer for a 12 months contract in Visp, Valais area of Switzerland.
In this role you will support the assigned project, create the requested CSV documents according to Companies SOP’s, execute the CSV tests, and support the CSV timelines with PM & CQV-Lead. This person should be available as soon as possible for the assigned project and fluent in English and German languages.
Main Responsibilities:
- Acting as subject matter expert (SME) on following Companies CQV / CSV standards
- CSV person of contact of the assigned system till the handover to the operation organization
- Participate to the system impact assessment as CSV SME
- Define with EMR and Package Units vendor the most appropriate design for vertical integration in the environment
- Create the requested CSV documents according to companies’ SOP’s and Guidelines
- Organize the reviews of the CSV documents till last QA approval
- Participate to the FAT & SAT
- Create the tests protocols and execute the tests
- Close collaboration with CSV Lead or CQV Lead
- Responsible for ensuring that SGIE projects in Visp are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with companies’ continuous improvement vision
- Participate in inspection as companies Project CSV-representative
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred
- Extensive experience in vertical integration and data management under validated computer systems.
- Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable.
- Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs.
- Strong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects.
- Proven management experience in an EMA / FDA regulated environment with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- Experience in People Management (internal and external) with respect to organizational aspects, coaching and development.
- Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment.
- Language: Excellent command of English and proven knowledge in German necessary (read and write) and other desirable.
- Strong analytical skills. Ability to conduct in-depth analysis of complex/large data sets, draw conclusions accordingly, and prepare and support decisions.
- Experience at working both independently and in a team-oriented environment.
- Ability to effectively prioritize and execute tasks in a fast-paced environment.
- Strong written and oral communication skills.
- Willing and able to train/support colleagues
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Information Technology and Engineering
Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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CSV Engineer - 7274 URA Arbeitgeber: CTC Resourcing Solutions AG
Kontaktperson:
CTC Resourcing Solutions AG HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: CSV Engineer - 7274 URA
✨Tip Number 1
Make sure to familiarize yourself with ISPE GAMP5 and ASTM guidelines, as these are crucial for the CSV Engineer role. Highlight any relevant experience you have in managing complex pharmaceutical projects during your discussions.
✨Tip Number 2
Since this position requires strong collaboration skills, be prepared to discuss examples of how you've successfully worked in a team-oriented environment. Emphasize your ability to influence and collaborate with various stakeholders.
✨Tip Number 3
Given the importance of compliance in this role, brush up on current ICH, PIC/S, EU, and US regulatory requirements. Being able to demonstrate your knowledge in these areas will set you apart from other candidates.
✨Tip Number 4
Since fluency in both English and German is required, practice discussing technical topics in both languages. This will help you feel more confident during interviews and show your readiness for the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: CSV Engineer - 7274 URA
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 Engineer position. Tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your extensive experience in Commissioning, Qualification, and Validation (CSV) within the pharmaceutical industry. Mention specific projects where you demonstrated your expertise in managing complex pharmaceutical projects.
Showcase Language Skills: Since fluency in English and German is essential, ensure that your language skills are clearly stated in your application. Provide examples of how you've used these languages in a professional context.
Prepare for Technical Questions: Be ready to discuss your knowledge of ISPE GAMP5, ASTM guidelines, and your experience with regulatory requirements during the interview process. Prepare examples that demonstrate your analytical skills and ability to manage data sets.
Wie du dich auf ein Vorstellungsgespräch bei CTC Resourcing Solutions AG vorbereitest
✨Showcase Your Expertise
As a CSV Engineer, you'll be expected to act as a subject matter expert. Be prepared to discuss your experience with CQV/CSV standards and how you've applied them in previous projects. Highlight specific examples where you successfully managed complex pharmaceutical projects.
✨Demonstrate Technical Knowledge
Familiarize yourself with ISPE GAMP5 and ASTM guidelines, as well as current ICH, PIC/S, EU, and US regulatory requirements. During the interview, be ready to explain how you've implemented these standards in your past roles, especially in regulated environments.
✨Emphasize Collaboration Skills
This role requires strong collaboration and influencing skills. Prepare to share examples of how you've worked effectively in a team-oriented environment, particularly in matrix organizations. Discuss any experiences where you led teams or coached colleagues.
✨Prepare for Language Proficiency Questions
Since fluency in English and German is essential, be ready to demonstrate your language skills during the interview. You might be asked to discuss technical topics in both languages, so practice explaining key concepts in German to ensure you're comfortable.
