Aseptic Validation Engineer – Media Fill Expert

Tech'Firm Industrie AG; Basel; On-site; CHF 110,000 - 150,000; Full time

Benefits offered by this job

International working environment

Long-term assignments

Professional development

Collaborative project teams

Job summary

Tech'Firm Industrie AG is seeking an experienced Process/Aseptic Validation Engineer to support Media Fill campaigns on a sterile filling line in Basel, Switzerland. You will ensure GMP compliance and coordinate cross-functional validation activities in a highly regulated environment.

The role requires extensive experience in aseptic processing, media fills, and collaboration with Production, QA, QC Microbiology and Validation teams.

Qualifications

• Degree in Pharmacy, Biotechnology, or related field.
• At least 10 years in sterile pharmaceutical manufacturing.
• Experience with Media Fill campaigns (APS).
• Knowledge of EU GMP Annex 1.
• Strong problem-solving and CAPA capabilities.

Responsibilities

• Coordinate and execute Media Fill campaigns.
• Ensure compliance with EU GMP Annex 1 requirements.
• Collaborate with QA, QC Microbiology and Validation teams.
• Support deviation investigations and CAPA implementations.
• Participate in qualification activities, including PQ.

Skills

Media Fill campaigns

Aseptic validation

GMP compliance

Root cause analysis

CAPA processes

Education

Pharmacy/Biotech/related field

Tools

Isolator technology

RABS technology

PQ equipment

Job description

Tech'Firm Industrie AG is seeking an experienced Process/Aseptic Validation Engineer to support Media Fill campaigns on a sterile filling line in Basel, Switzerland. You will ensure GMP compliance and coordinate cross-functional validation activities in a highly regulated environment.

The role requires extensive experience in aseptic processing, media fills, and collaboration with Production, QA, QC Microbiology and Validation teams.