Sterility Assurance Lead: Contamination Control Expert

Ten23 Health; Oberwallis; Remote; CHF 190,000 - 230,000; Full time

Benefits offered by this job

Flexible working arrangements

Competitive pension fund

Annual bonus

Training & development options

Job summary

ten23 health is seeking an accomplished Sterility Assurance & Contamination Control Lead to guide the CCS strategy for our GMP-regulated sterile manufacturing operations. You will shape site-wide sterility programs and ensure compliance with EU GMP Annex 1 and global regulators.

We are looking for a proven leader with deep aseptic knowledge, cleanroom design expertise, and a track record of remediation and inspection readiness. Join a dynamic team driving patient-safe injectable medicines.

Qualifications

• Proven extensive experience in GMP-regulated sterile manufacturing environments.
• Leadership in designing and implementing contamination control strategies.
• Strong technical background in cleanroom design, qualification and control.
• Experience with regulatory remediation in sterile manufacturing.
• Expertise in leading sterility assurance investigations.

Responsibilities

• Lead the site contamination control strategy (CCS) across sterile operations.
• Design, implement and continuously improve sterility assurance programs aligned with EU GMP Annex 1 and global expectations.
• Oversee aseptic facility design, qualification, and control (HVAC zoning, flows, RABS/isolators).
• Drive regulatory remediation activities and requalification of clean areas when needed.
• Lead investigations of sterility failures, contamination events, and media fill excursions.
• Institute operator qualification, aseptic technique training, gowning, and personnel monitoring programs.
• Support tech transfer, facility startup, and process validation with sterility integrity in mind.
• Perform cross-functional risk assessments (FMEA/HACCP) to mitigate microbial risk.
• Monitor data trends and environmental monitoring to trigger preventive actions.
• Prepare for and support regulatory inspections and client audits.

Skills

GMP sterile manufacturing

Contamination control leadership

Cleanroom design & qualification

Regulatory remediation

Sterility investigations

Operator qualification programs

Risk assessments (FMEA/HACCP)

Data trending & preventive actions

Tools

Environmental monitoring systems

GMP systems

Job description

ten23 health is seeking an accomplished Sterility Assurance & Contamination Control Lead to guide the CCS strategy for our GMP-regulated sterile manufacturing operations. You will shape site-wide sterility programs and ensure compliance with EU GMP Annex 1 and global regulators.

We are looking for a proven leader with deep aseptic knowledge, cleanroom design expertise, and a track record of remediation and inspection readiness. Join a dynamic team driving patient-safe injectable medicines.