Make your mark for patients
We are looking for a CSV & Automation Qualification Specialist who is detail-oriented, proactive, and highly organized to join us in our Qualification team, based in our UCB office in Bulle, Switzerland.
About the role
As a CSV & Automation Qualification Specialist, you will manage automation and computerized system qualification in compliance with regulatory and company procedures. You will provide expertise during investigations, change controls, and projects, and present qualification documentation during audits.
Who you’ll work with
You will be part of qualification team which promotes continuous improvement and supports projects involving equipment, automation systems, computerized systems and utilities qualification. You will collaborate with cross-functional teams including Automation, Projects Leads, Manufacturing and QA to ensure qualification activities meet cGMP requirements.
What you’ll do
- Define and lead global qualification strategies and risk assessments
- Write qualification plans, protocols, and reports
- Ensure the correct qualification of GMP installations (automation, softwares, logic controllers, utilities)
- Maintain qualification activity planning and coordinate with external partners
- Lead qualification-related projects and participate in cross-functional initiatives
- Act as SME during audits and inspections presenting qualification documentation
Interested? For this role we’re looking for the following education, experience and skills
- In-depth knowledge of cGMP and biotech/pharmaceutical manufacturing regulations
- Excellent knowledge of Automation systems and software structure, components and communication links between the technological layers from IT infra and shopfloor components up to global infra layers such as ERP/MES systems.
- Minimum 3 years’ experience in pharmaceutical manufacturing and system qualification
- Expertise in computerized system validation and automation systems PLC/SCADA/DCS/MES
- Proficiency in French and English, both spoken and written
- Strong communication, organizational, and problem-solving skills
- Ability to work autonomously with excellent stress management
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!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on E-Mail schreiben. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
