Site-Based MSAT Process Validation Expert

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Competitive hourly rate

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Process validation

Cleaning validation

cGMP awareness

Regulatory inspections

Technical writing

Cross-functional collaboration

Quality systems

Ausbildung

Master's or PhD in biotechnology or life sciences

Jobbeschreibung

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