QA Validation Specialist 2

Join our dynamic QA Validation & Qualifications team in Visp to lead critical compliance and qualification activities for Project Monarch, our state-of-the-art biomanufacturing facility expansion within BioAtrium. You will play a pivotal role in ensuring advanced process control systems, clean utilities, and equipment consistently deliver high-quality biopharmaceuticals that save patients' lives.

Fully site‑based roles

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

An agile career and dynamic working culture.

An inclusive and ethical workplace.

Competitive hourly rate.

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• Perform QA oversight for validation review and qualification activities, guaranteeing biomanufacturing equipment, clean utilities, and facilities continuously maintain a compliant state.

• Drive Project Monarch forward by participating directly in a major, large-scale mammalian cell culture expansion within BioAtrium.

• Assess and approve change controls, deviations, CAPAs, and standard operating procedures (SOPs) to enforce strict regulatory adherence.

• Author and review critical IQ/OQ/PQ protocols, validation plans, temperature mapping reports, and shipping validation records.

• Work collaboratively with cross-functional partners in Operations, Engineering, external clients, and regulatory bodies.

• Utilize advanced digital quality systems daily, including Kneat, TrackWise, LIMS, and Document Management Systems (DMS).

• Support audit and inspection readiness to showcase site compliance with European (EMA) and US (FDA) regulations.

What we are looking for:

• Proven experience (2–6 years) in validation or qualification within a GMP-regulated biotech, pharmaceutical, or cell and gene therapy setting.

• Strong technical expertise across the validation lifecycle, including IQ/OQ/PQ, equipment qualification, autoclaves, and clean utilities.

• Demonstrated experience reviewing and approving SOPs, validation protocols, change controls, CAPAs, and deviations.

• Solid understanding of EU GMP and FDA regulatory expectations.

• Practical familiarity with digital validation and quality tools such as Kneat, TrackWise, or LIMS.

• Professional proficiency in English is required; German skills are a strong plus.

• A relevant academic background in Engineering, Biotechnology, Science, or equivalent hands-on industry experience.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.

Ready to play your part in shaping the future of life sciences? Apply now.