Sterility Assurance Lead - Contamination Control Expert

Lonza

Oberwallis

Vor Ort

Vertraulich

Vollzeit

14 Tage+
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Benefits dieser Stelle

Agile career & dynamic culture
Inclusive & ethical workplace
Performance-based compensation
Location-based benefits

Zusammenfassung

Lonza in Visp, Switzerland seeks a Sterility Assurance Lead (SAL) to own and drive the Contamination Control Strategy, partnering with Operations, QA/QC, and global teams to assure sterility and regulatory compliance across aseptic processing and environmental monitoring.

The role requires leading investigations, CAPA, and continuous improvement, with strong microbiology knowledge and GMP experience. Fluency in English is required; German is an advantage.

Qualifikationen

  • Academic degree in a scientific discipline with extensive experience in microbial control in pharma.
  • Hands-on expertise in contamination control, aseptic processing, APS, environmental monitoring, and microbiological investigations.
  • Deep knowledge of cleanroom engineering, sterilization, microbiological testing, and risk management.
  • Excellent communication, decision making, conflict resolution, and change management in complex ops.
  • Strong understanding of GMP and pharmaceutical regulations.
  • Fluent English; German is an advantage.

Aufgaben

  • Own and improve the Contamination Control Strategy (CCS).
  • Provide technical leadership for aseptic processing, APS, sterilization, cleanrooms, and contamination control.
  • Serve as Sterility Assurance SME for facility design, tech transfers, and risk assessments.
  • Lead investigations, CAPA, and root-cause analyses on sterility topics.
  • Manage environmental monitoring strategies, metrics, trends, and improvement.
  • Represent Sterility Assurance during inspections and audits.

Kenntnisse

Sterility assurance
Aseptic processing
Environmental monitoring
Regulatory compliance
Quality leadership
GxP knowledge

Ausbildung

Scientific degree

Tools

LIMS
Cleanroom systems

Jobbeschreibung

Lonza in Visp, Switzerland seeks a Sterility Assurance Lead (SAL) to own and drive the Contamination Control Strategy, partnering with Operations, QA/QC, and global teams to assure sterility and regulatory compliance across aseptic processing and environmental monitoring.

The role requires leading investigations, CAPA, and continuous improvement, with strong microbiology knowledge and GMP experience. Fluency in English is required; German is an advantage.

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