Senior Specialist QC Microbio

Location: Yverdon-les-Bains, Switzerland

Company

hirify.global is a biotechnology company developing and manufacturing pharmaceutical products.

What you will do

• Plan, coordinate, and prioritize QC Microbiology activities supporting production and batch release.
• Perform and oversee Bioburden, Endotoxin (LAL), Sterility, Environmental Monitoring, and Utilities Monitoring testing.
• Review, approve, and trend microbiological data and analytical documentation in accordance with GMP and data integrity requirements.
• Act as the subject matter expert for microbiological method verification, validation, transfer, and lifecycle management.
• Lead deviations, investigations, root cause analyses, CAPAs, change controls, audits, and inspection-readiness activities.
• Provide technical guidance and coaching while contributing to laboratory digitalization, automation, and continuous improvement.

Requirements

• Bachelor’s degree in Microbiology, Biotechnology, Life Sciences, or a related scientific discipline.
• At least 5 years of relevant QC Microbiology experience in a GMP-regulated pharmaceutical or biotechnology environment.
• Hands-on experience with Bioburden, Endotoxin, Sterility Testing, Environmental Monitoring, and Utilities Monitoring.
• Knowledge of microbiological testing, aseptic techniques, USP, Ph. Eur., JP, GMP, data integrity, and quality risk management.
• French: fluent; English: advanced, minimum C1.
• Experience with LIMS, electronic quality systems, and Microsoft Office; weekend and out-of-hours work may be required.

Culture & Benefits

• High degree of autonomy, accountability, and ownership.
• Cross-functional collaboration with Quality Assurance, Manufacturing, Engineering, Validation, Supply Chain, Warehouse, and external laboratories.
• Opportunity to coach laboratory personnel and contribute to quality culture and continuous improvement.