MSAT Process Validation Expert

Lonza; Oberwallis; Sur place; Vertraulich; Plein temps

Avantages offerts par ce poste

Competitive hourly rate

Résumé du poste

Lonza in Visp, Switzerland, is seeking a site-based Validation Specialist to drive process and cleaning validation for mammalian cell culture projects. You will author protocols, support PQ studies, and serve as SME during regulatory inspections, collaborating with MSAT, Quality and Manufacturing to ensure compliance.

The role emphasizes technical writing, data analysis, and ongoing SOP refinement to meet evolving industry standards, with an agile, collaborative work culture and competitive

Qualifications

• Hands-on experience in process validation within a cGMP biopharmaceutical environment.
• Experience with cleaning validation is preferred.
• Strong technical foundation in upstream/downstream bioprocesses, ideally mammalian cell culture.
• Proven ability to manage complex validation tasks and produce technical documents.
• Experience with quality records, change controls, and deviation investigations.

Responsabilités

• Drive and execute process and cleaning validation strategies for mammalian cell culture projects in Visp.
• Author, review, and approve validation protocols and reports per cGMP and Lonza procedures.
• Act as SME during health authority inspections and customer audits.
• Support PQ studies related to upstream and downstream validation activities.
• Evaluate data against acceptance criteria and lead investigations for deviations.
• Collaborate with MSAT, Quality, and Manufacturing; represent Lonza in customer meetings.
• Develop and refine SOPs and validation programs to meet evolving industry standards.

Connaissances

Process validation

Cleaning validation

cGMP awareness

Regulatory inspections

Technical writing

Cross-functional collaboration

Quality systems

Formation

Master's or PhD in biotechnology or life sciences

Description du poste

This is a fully site-based role located in Visp, Switzerland, supporting the Project Orca expansion in the Ibex Biopark. You will play a crucial role in ensuring process and cleaning validation standards meet strict cGMP compliance for client-facing mammalian cell culture manufacturing.

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.

What you will do:

• Drive and execute process and cleaning validation strategies for assigned mammalian cell culture biopharmaceutical projects in the Visp facility.
• Author, review, and approve validation protocols, technical reports, and non-conformity records (DRs) in alignment with cGMP standards and Lonza procedures.
• Serve as a Subject Matter Expert (SME) during health authority inspections (e.g., Swissmedic, FDA) and customer audits.
• Support performance qualification (PQ) studies related to upstream and downstream process validation activities.
• Evaluate validation data against established acceptance criteria and lead technical investigations for process deviations.
• Collaborate closely with cross‑functional teams across MSAT, Quality, and Manufacturing, directly representing Lonza in customer‑facing meetings.
• Assist in developing and refining Standard Operating Procedures (SOPs) and validation programs to continuously meet evolving industry standards.

What we are looking for:

• Degree in biotechnology, life sciences, or a related discipline (Master's or PhD preferred).
• Hands‑on experience in process validation (and ideally cleaning validation) within a cGMP‑regulated biopharmaceutical environment.
• Strong technical foundation in upstream and downstream bioprocesses, preferably focused on mammalian cell culture manufacturing.
• Proven track record of managing complex validation tasks, technical writing, and navigating regulatory agency expectations.
• Demonstrated experience handling quality records, change controls, and deviation investigations.
• Strong cross‑functional stakeholder management and professional communication skills.
• Professional fluency in English (written and spoken); working knowledge of German is an advantage.

About Lonza

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

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they 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.