Overview
QA Validation Specialist– BioAtrium Jobs in Visp, Valais, Switzerland at Lonza
Title: QA Validation Specialist– BioAtrium
Company: Lonza
Location: Visp, Valais, Switzerland
Are you ready to support the expansion of one of the world's most advanced biologics manufacturing sites? We are looking for an autonomous, fast-learning QA Validation Specialist to join our validation team in Visp for a critical 4-month period, ensuring that our large-scale mammalian cell culture facilities and clean utilities remain in a continuously compliant, fully validated state.
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
- Contract assignment – 4 months / 41 hours per week
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
What you will do:
- Provide direct QA oversight of commissioning, qualification, and validation (CQV) activities on-site in Visp to keep advanced biologics equipment and facilities in a continuously validated state.
- Perform robust quality assessments and execute change controls for GMP equipment, clean utilities, autoclaves, and complex process control systems.
- Thoroughly review and approve high-priority GMP documentation, including SOPs, validation protocols (IQ/OQ/PQ), and validation reports.
- Actively manage quality events within electronic systems, taking ownership of deviations, CAPAs, and change controls to prevent project bottlenecks.
- Schedule and coordinate your validation tasks, ensuring clean utilities and temperature-controlled storage rooms meet project milestones.
- Ensure all qualification and validation activities strictly comply with European (EU GMP) and US (FDA) regulatory expectations.
- Collaborate closely with cross-functional teams, including Operations, Engineering, and external clients, to maintain alignment during this critical project phase.
What we are looking for:
- Experience: 2–6 years of hands-on validation and qualification experience within a highly regulated GMP pharmaceutical, biotechnology, or cell & gene therapy environment.
- Key Qualifications: A deep understanding of the validation lifecycle, including hands-on experience reviewing and approving IQ/OQ/PQ protocols, thermal mapping, autoclaves, and clean utilities.
- Quality Systems: Strong familiarity with computerized validation and quality systems such as Trackwise (for Deviations, CAPAs, and Change Controls) and Kneat.
- Regulations: Sound knowledge of EU GMP and US FDA regulatory standards.
- Education: A Bachelor's degree in Engineering, Biotechnology, Chemistry, Pharmacy, or a related scientific discipline (equivalent practical industry experience will also be highly valued).
- Languages: Professional proficiency in English is required; German language skills are a strong asset for communicating with local site teams.
- Working Style: An autonomous self-starter who thrives in a fast-paced, collaborative, and multicultural environment.
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.
