Aseptic Validation Engineer – Media Fill Expert

TechFirm Engineering; Basel; On-site; CHF 120,000 - 190,000; Full time

Benefits offered by this job

International environment

Long-term assignments

Professional development

Job summary

TechFirm Engineering is seeking an experienced Aseptic Validation Engineer – Media Fill (m/f/d) to contribute to pharmaceutical projects in Switzerland. You will drive Media Fill campaigns, validate aseptic processes and ensure GMP compliance.

Work closely with Production, QA, QC Microbiology and Validation teams to meet critical milestones. A degree in Pharmacy/Biotech/Process Engineering and 10+ years in sterile manufacturing are required.

Qualifications

• Degree or equivalent qualification in Pharmacy, Biotechnology, Process Engineering, Chemistry or related field.
• At least 10 years of experience in sterile pharmaceutical manufacturing, particularly aseptic Fill & Finish.
• Proven hands-on experience in the preparation, execution and follow-up of Media Fill campaigns (APS).
• Strong knowledge of aseptic process validation and EU GMP Annex 1 requirements.

Responsibilities

• Plan, prepare, execute and follow-up Media Fill campaigns (APS) in sterile manufacturing.
• Coordinate and actively participate in preparation, planning and execution of Media Fill campaigns.
• Oversee campaign activities, monitor execution and review results.
• Contribute to aseptic process validation activities and CAPA processes.
• Participate in equipment and process qualification activities, including PQ when required.

Skills

Media Fill campaigns

Aseptic manufacturing

GMP environments

Isolator/RABS experience

CAPA processes

Cross-functional teamwork

Education

Pharmacy

Biotechnology

Process Engineering

Chemistry

Tools

SKAN

Syntegon

Groninger

Bausch+Strobel

Optima

Vanrx

Job description

TechFirm Engineering is seeking an experienced Aseptic Validation Engineer – Media Fill (m/f/d) to contribute to pharmaceutical projects in Switzerland. You will drive Media Fill campaigns, validate aseptic processes and ensure GMP compliance.

Work closely with Production, QA, QC Microbiology and Validation teams to meet critical milestones. A degree in Pharmacy/Biotech/Process Engineering and 10+ years in sterile manufacturing are required.