Qualification Specialist
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
- Internal Manufacturing, and Automation teams.
- Quality Assurance, IT and Regulatory functions.
- Project teams and external qualification partners.
- Health authorities and auditors during inspections.
What you’ll do
- Define and implement qualification strategies for computerized and automation systems in compliance with cGMP and regulatory requirements.
- Author, review and maintain qualification documentation, including risk assessments, plans, protocols, reports, QMF and PQR.
- 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.
- Act as a subject matter expert for qualification activities during deviations, change controls, investigations and audits.
- Support site projects and continuous improvement initiatives by contributing qualification expertise within cross‑functional teams.
- Present qualification strategies and documentation during inspections and audits by health authorities and partners.
Interested? For this role we’re looking for the following education, experience and skills
- Bachelor’s or master’s degree in engineering, Life Sciences or a related discipline.
- At least 3 years of experience in pharmaceutical or biotechnological manufacturing.
- Solid expertise in Computerized System Validation (CSV) and hands-on experience with automation system (preferably with Syncade, Delta V).
- Strong knowledge of cGMP and regulated environments, GAMP requirements, Data Integrity principles and quality systems.
- Strong organizational, communication and problem‑solving skills.
- High capacity to anticipate issues, identify priorities and make decisions.
- High level of autonomy and good stress management skills.
- Solution-oriented and sensitive to customer needs.
- Pragmatic and critical-minded.
- Sense of responsibility and ownership.
- Sense of initiative.
- 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!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 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.
At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.
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 [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
