Sterility Assurance Lead: Aseptic Excellence & Compliance

Lonza Group; Oberwallis; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Relocation assistance

Competitive compensation

Dynamic working culture

Inclusive workplace

Benefits depend on role and location

Zusammenfassung

Lonza Group in Visp, Switzerland, seeks a Sterility Assurance Lead to drive the Sterility Assurance and Microbial Control program for the Drug Product Module at the Visp site. The role leads the Contamination Control Strategy, ensures regulatory compliance, and partners across operations, QA, QC, and global functions.

The candidate will provide technical leadership for aseptic processing, environmental monitoring, and investigations, and act as SME for facility design and technology transfers.

Qualifikationen

• Academic degree in a scientific discipline with extensive experience in microbial control and sterility assurance within the pharmaceutical industry.
• Strong hands-on expertise in contamination control, aseptic processing, APS, environmental monitoring, and complex microbiological investigations.
• Deep knowledge of cleanroom engineering, sterilization processes, microbiological testing methodologies, and contamination risk management.
• Excellent communication, decision making, conflict resolution, and change management skills in complex operational environments.
• Comprehensive understanding of pharmaceutical regulations and GMP requirements.
• Strong technical knowledge of USP/EP requirements, bioburden, endotoxin, sterility testing, environmental monitoring, and contamination control systems.
• Business fluent English is required; German is an advantage.

Aufgaben

• Owns and continuously improves the Contamination Control Strategy (CCS), ensuring compliance with regulatory requirements and Lonza guidelines.
• Provide technical leadership for aseptic processing, APS, sterilization, cleanroom management, and contamination control programs.
• Act as Sterility Assurance SME for facility design, technology transfers, and contamination risk assessments.
• Lead investigations, CAPAs, and root cause analyses related to sterility assurance topics.
• Manage environmental monitoring strategies, metrics, trend analysis, and continuous improvement initiatives.
• Represent Sterility Assurance during health authority inspections, customer audits, and cross-functional platforms.

Kenntnisse

Sterility assurance

Microbial control

Aseptic processing

Environmental monitoring

Microbiological testing

Cleanroom engineering

GMP knowledge

Regulatory compliance

Ausbildung

Science degree

Jobbeschreibung

Lonza Group in Visp, Switzerland, seeks a Sterility Assurance Lead to drive the Sterility Assurance and Microbial Control program for the Drug Product Module at the Visp site. The role leads the Contamination Control Strategy, ensures regulatory compliance, and partners across operations, QA, QC, and global functions.

The candidate will provide technical leadership for aseptic processing, environmental monitoring, and investigations, and act as SME for facility design and technology transfers.