Sterility Assurance Lead: Aseptic & Contamination Control

Lonza; Lavamünd; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Compensation programs

Benefits variety

Zusammenfassung

Lonza in Visp, Switzerland seeks a Sterility Assurance Lead (SAL) to head the Contamination Control Strategy and drive sterility assurance across Drug Product workflows. You will partner with Operations, QA/QC, microbiology, engineering and global functions to ensure regulatory compliance and continuous improvement in aseptic processing.

The role requires deep expertise in contamination control, aseptic processing, environmental monitoring and complex microbiological investigations, plus strong

Qualifikationen

• Academic background in microbiology, biopharma or related science.
• Strong hands‑on expertise in aseptic processing, contamination control and microbial investigations.
• Familiarity with USP/EP, sterility testing and environmental monitoring.
• Experience supporting regulatory inspections and cross‑functional collaboration.

Aufgaben

• Own and continuously improve the Contamination Control Strategy (CCS) and ensure regulatory compliance.
• Provide technical leadership for aseptic processing, APS, sterilization and cleanroom management.
• Act as Sterility Assurance SME for facility design, tech transfers and risk assessments.
• Lead investigations, CAPAs and root-cause analyses related to sterility topics.
• Manage environmental monitoring strategies, metrics and trend analysis.
• Represent Sterility Assurance during health authority inspections and audits.

Kenntnisse

Microbial control

Aseptic processing

Environmental monitoring

Sterility assurance

Regulatory knowledge GMP

Ausbildung

Scientific degree in pharmaceutical or related field

Jobbeschreibung

Lonza in Visp, Switzerland seeks a Sterility Assurance Lead (SAL) to head the Contamination Control Strategy and drive sterility assurance across Drug Product workflows. You will partner with Operations, QA/QC, microbiology, engineering and global functions to ensure regulatory compliance and continuous improvement in aseptic processing.

The role requires deep expertise in contamination control, aseptic processing, environmental monitoring and complex microbiological investigations, plus strong