Make your mark for patients
We are looking for an CSV & Automation Qualification Specialist, who is eager to join our Internal Manufacturing department, based in our manufacturing site in Bulle, Switzerland.
About the role
As a CSV & Automation Qualification Specialist, you are responsible for ensuring that computerized and automated systems used in GMP manufacturing are qualified, compliant, and fit for use throughout their lifecycle. You work on a wide range of systems, from standalone software to PLC/SCADA platforms, DCS batch control and MES electronic batch records, while ensuring compliance with cGMP, Data Integrity and GAMP requirements. You actively support inspections, audits, site projects and continuous improvement initiatives.
Who you’ll work with
1. Internal Manufacturing, and Automation teams.
2. Quality Assurance, IT and Regulatory functions.
3. Project teams and external qualification partners.
4. Health authorities and auditors during inspections.
What you’ll do
5. Define and implement qualification strategies for computerized and automation systems in compliance with cGMP and regulatory requirements.
6. Author, review and maintain qualification documentation, including risk assessments, plans, protocols, reports, QMF and PQR.
7. Ensure proper qualification/validation of computerized systems and softwares, DCS Batch recipes (Emerson Delta V), MES workflows and recipes (Syncade) and PLC and SCADA systems.
8. Act as a subject matter expert for qualification activities during deviations, change controls, investigations and audits.
9. Support site projects and continuous improvement initiatives by contributing qualification expertise within cross‑functional teams.
10. Present qualification strategies and documentation during inspections and audits by health authorities and partners.
Interested? For this role we’re looking for the followingeducation, experienceand skills
11. Bachelor’s or master’s degree in engineering, Life Sciences or a related discipline.
12. At least 3 years of experience in pharmaceutical or biotechnological manufacturing.
13. Solid expertise in Computerized System Validation (CSV) and hands-on experience with automation system (preferably with Syncade, Delta V).
14. Strong knowledge of cGMP and regulated environments, GAMP requirements, Data Integrity principles and quality systems.
15. Strong organizational, communication and problem‑solving skills.
16. High capacity to anticipate issues, identify priorities and make decisions.
17. High level of autonomy and good stress management skills.
18. Solution-oriented and sensitive to customer needs.
19. Pragmatic and critical-minded.
20. Sense of responsibility and ownership.
21. Sense of initiative.
22. Fluency in English and French, written and spoken.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!