Sterility Assurance Lead — Contamination Control (GMP)

ten23 health; Oberwallis; Presencial; CHF 170.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development

Flexible working arrangements

Learning culture

Pension plan

Annual bonus

Descripción de la vacante

ten23 health seeks an accomplished Sterility Assurance & Contamination Control Lead to drive our comprehensive contamination control strategy in sterile manufacturing. You will be a recognized expert in GMP-regulated sterile environments, ensuring top quality and regulatory compliance across the site.

Responsibilities include designing, implementing, and continuously improving a robust CCS, leading sterility investigations, and overseeing aseptic qualification programs, operator training, and

Formación

• Proven extensive experience in GMP-regulated sterile environments.
• Leadership in designing and implementing contamination control strategies.
• Strong technical background in cleanroom design and qualification.

Responsabilidades

• Lead and continually improve the Contamination Control Strategy across the site.
• Oversee aseptic facilities, qualification, and operation in regulated sterile manufacturing.
• Drive regulatory remediation and investigations into sterility issues and test failures.
• Ensure operator qualification programs and personnel monitoring meet regulatory standards.
• Support tech transfer, facility startup, and process validation with sterility considerations.
• Conduct risk assessments (FMEA, HACCP) to identify microbial risks and preventive actions.
• Prepare for and manage regulatory inspections and client audits regarding sterility.

Conocimientos

GMP-regulated sterile manufacturing

Contamination Control Strategies

Cleanroom design

Aseptic technique

Aseptic qualification programs

Regulatory inspections readiness

Risk assessments (FMEA, HACCP)

Environmental monitoring programs

Descripción del empleo

ten23 health seeks an accomplished Sterility Assurance & Contamination Control Lead to drive our comprehensive contamination control strategy in sterile manufacturing. You will be a recognized expert in GMP-regulated sterile environments, ensuring top quality and regulatory compliance across the site.

Responsibilities include designing, implementing, and continuously improving a robust CCS, leading sterility investigations, and overseeing aseptic qualification programs, operator training, and