Sterility Assurance Lead: Contamination Control Expert

Ten23 Health; Oberwallis; On-site; CHF 180,000 - 240,000; Full time

Benefits offered by this job

Pension plan

Annual bonus

Training & development

Flexible working arrangements

Job summary

ten23 health is seeking an accomplished Sterility Assurance & Contamination Control Lead to guide our containment program in sterile manufacturing. You will drive the CCS design, oversee aseptic processes, and prepare for regulatory inspections to ensure product quality and compliance.

You will lead complex investigations, supervise operator qualification, and collaborate across functions to mitigate microbial risks throughout the product lifecycle.

Qualifications

• Extensive experience in GMP-regulated sterile manufacturing.
• Design and implement Contamination Control Strategies.
• Strong cleanroom design, qualification, and control expertise.
• Experience with regulatory remediation in sterile manufacturing.
• Proven leadership in sterility assurance investigations.
• Aseptic operator qualification and training knowledge.
• Experience with tech transfer, facility startup and process validation.
• Cross-functional risk assessments (FMEA, HACCP) experience.
• Ability to analyze trending data and drive preventive actions.

Responsibilities

• Lead and implement the Contamination Control Strategy aligned with EU GMP Annex 1.
• Manage site-wide sterility assurance strategy across operations.
• Oversee aseptic processes, cleanroom qualification, HVAC systems.
• Lead investigations of sterility events and test failures.
• Coordinate operator qualification programs and training.
• Prepare for regulatory inspections and client audits.
• Collaborate on risk assessments across functions.
• Drive continuous improvement in contamination control.

Skills

GMP Sterile

Leadership

Contamination Control

Regulatory Compliance

Aseptic Processing

Cleanroom Design

Job description

ten23 health is seeking an accomplished Sterility Assurance & Contamination Control Lead to guide our containment program in sterile manufacturing. You will drive the CCS design, oversee aseptic processes, and prepare for regulatory inspections to ensure product quality and compliance.

You will lead complex investigations, supervise operator qualification, and collaborate across functions to mitigate microbial risks throughout the product lifecycle.