CSV Engineer (6274)

CSV Engineer– 6274 URA

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 the company’s SOPs, 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:

1. Acting as subject matter expert (SME) on following Companies CQV / CSV standards
2. CSV person of contact for the assigned system till the handover to the operation organization
3. Participate in the system impact assessment as CSV SME
4. Define with EMR and Package Units vendor the most appropriate design for vertical integration in the environment
5. Create the requested CSV documents according to companies’ SOPs and Guidelines
6. Organize the reviews of the CSV documents till last QA approval
7. Participate in the FAT & SAT
8. Create the test protocols and execute the tests
9. Close collaboration with CSV Lead or CQV Lead
10. 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
11. Participate in inspection as companies Project CSV-representative

Qualifications and Experience:

1. Relevant working/residency permit or Swiss/EU-Citizenship required
2. Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred
3. Significant experience in automation
4. Extensive experience in vertical integration and data management under validated computer systems.
5. 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.
6. 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.
7. Strong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects.
8. 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.
9. Experience in People Management (internal and external) with respect to organizational aspects, coaching and development.
10. Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment.
11. Language: Excellent command of English and proven knowledge in German necessary (read and write) and other desirable.
12. Strong analytical skills. Ability to conduct in-depth analysis of complex/large data sets, draw conclusions accordingly, and prepare and support decisions.
13. Experience at working both independently and in a team-oriented environment.
14. Ability to effectively prioritize and execute tasks in a fast-paced environment.
15. Strong written and oral communication skills.
16. Willing and able to train/support colleagues.

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