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Lonza

Global life sciences contract manufacturer

Sterility Assurance Lead - Drug Product

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeVisp, SwitzerlandNo salary listed

About the Job

Requirements

  • An academic degree in a scientific discipline and extensive experience in microbial control and sterility assurance within the pharmaceutical industry.
  • Strong hands-on expertise in contamination control, aseptic processing, aseptic process simulations (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 Good Manufacturing Practice (GMP) requirements.
  • Strong technical knowledge of USP/EP requirements, bioburden, endotoxin, sterility testing, environmental monitoring, and contamination control systems.
  • Business-fluent English is required.

Responsibilities

  • Own and continuously improve the Contamination Control Strategy (CCS), ensuring compliance with regulatory requirements, company guidelines, and industry best practices.
  • Provide technical leadership and oversight for aseptic processing, aseptic process simulations (APS), sterilization, cleanroom management, and contamination control programs.
  • Act as the Sterility Assurance subject matter expert (SME) for facility design, technology transfers, and contamination risk assessments.
  • Lead investigations, corrective and preventive actions, and root cause analyses related to sterility assurance topics.
  • Manage environmental monitoring strategies, performance metrics, trend analysis, and continuous improvement initiatives to strengthen microbial control.
  • Represent Sterility Assurance during health authority inspections, customer audits, and cross-functional platforms.

Desired Qualifications

  • German is an advantage.

About the Company

Lonza

Global life sciences contract manufacturer

Lonza is a global provider of development and manufacturing services for the pharmaceutical, biotechnology, and nutrition sectors. It supports clients from early development through to commercial production, offering integrated processes such as process development, GMP manufacturing, formulation, fill-finish, and quality assurance to bring medicines and nutrition products to market. Lonza’s model is built on end-to-end CDMO capabilities, enabling companies to move from concept to scalable, compliant production with reliable supply chains. What sets Lonza apart is its long history and global footprint, combining decades of experience across chemistry, biology, and nutrition with a broad, end-to-end service network that supports projects from discovery to commercialization. The company aims to be a trusted, long-term partner in life sciences by helping customers efficiently develop and manufacture their products at scale while maintaining strict regulatory and quality standards.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1897

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