Aseptic Process Expert – Sterile Fill/Finish Specialist

ten23 health; Oberwallis; On-site; CHF 120,000 - 180,000; Full time

Benefits offered by this job

Career development

Flexible work

Mentorship

Training options

Pension plan

Annual bonus

Job summary

ten23 health seeks a Process Expert in Visp to drive aseptic manufacturing processes for sterile parenteral products. You will oversee process data evaluation, CAPA-driven improvements, and cross-functional collaboration to ensure compliant, robust production.

The role requires deep expertise in fill-finish, filtration, and lyophilization, with strong GMP knowledge and audit experience. Start Jan 1, 2027, through Aug 31, 2027, on-site in Visp, Switzerland.

Qualifications

• University degree in Pharmacy, Biotechnology, Chemistry, Process or Mechanical Engineering, or a related technical/natural science.
• At least 5+ years in sterile pharmaceutical manufacturing with deep knowledge of fill-finish, filtration, and lyophilization.
• In-depth understanding of EU-GMP Annex 1, FDA 21 CFR 210/211, and ISO cleanroom standards with experience in inspections/audits.
• Strong experience in aseptic techniques, validation, and qualification with statistical methods and modern data analysis tools.
• Highly structured thinker with the ability to conduct root-cause analyses and make data-driven decisions.
• Excellent communication skills in German and English for cross-functional guidance.
• A resilient, responsible professional balancing teamwork with high quality manufacturing processes.

Responsibilities

• Serve as SME for aseptic manufacturing processes (filtration, filling, sterilization, VHP).
• Provide scientific support for transfer of new products into manufacturing.
• Investigate complex deviations with root-cause analyses and track CAPAs.
• Troubleshoot shopfloor issues and coach staff on GMP practices.
• Author/maintain process documentation, SOPs, and change evaluations.
• Support equipment, cleanroom and system qualifications; oversee validations.
• Conduct CPP/CQAs trend analyses to identify risks and inform decisions.
• Represent technical topics during audits and inspections.

Skills

Aseptic manufacturing

Root-cause analysis

Data analysis

Cross-functional communication

GMP compliance

Education

University degree in Pharmacy/related science

Tools

Statistical analysis tools

Industry-standard QA/QC tools

Job description

ten23 health seeks a Process Expert in Visp to drive aseptic manufacturing processes for sterile parenteral products. You will oversee process data evaluation, CAPA-driven improvements, and cross-functional collaboration to ensure compliant, robust production.

The role requires deep expertise in fill-finish, filtration, and lyophilization, with strong GMP knowledge and audit experience. Start Jan 1, 2027, through Aug 31, 2027, on-site in Visp, Switzerland.