Global Microbiology Lead – Small Molecules Validation

Pauwels Consulting; Beerse; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

Pauwels Consulting seeks a Microbiology Expert – Small Molecules to support clinical and lifecycle management programs in a GMP-regulated environment. You will coordinate global microbiology activities and provide scientific input on method development, qualification, validation and transfer.

Fluent in English with 3+ years in pharma, you will lead cross-site microbiology projects, review validation docs, and ensure compliance with GMP/GxP standards while partnering with external and internal

Qualifikationen

• Master's degree in Pharmaceutical Microbiology, Life Sciences, or a related field.
• 3+ years of experience in a GMP-regulated pharmaceutical environment.
• Knowledge of contamination control, sterility assurance, bioburden, and bacterial endotoxin.
• Experience with microbiological method validation, qualification, and transfer.
• Experience with Small Molecules and PET/AET, ATP bioluminescence, and microbial purity.
• Strong project management and stakeholder influence in a global matrix organization.
• Fluent in English.

Aufgaben

• Lead and coordinate microbiology-related R&D and Lifecycle Management projects for Small Molecule products.
• Provide scientific input on microbiological method development, qualification, validation, and specification setting.
• Act as project lead for global method transfer and harmonization activities across various sites and external partners.
• Review and approve development reports, validation documentation, and microbiological test methods including sterility, bioburden, and bacterial endotoxin.
• Coordinate and follow up on Change Controls and specification documents within the microbiology domain.
• Ensure compliance with all relevant GMP, GxP, and regulatory standards.

Kenntnisse

Microbiology

GMP compliance

Project management

Stakeholder influence

English proficiency

Ausbildung

Master's degree in Pharmaceutical Microbiology

Tools

Quality management systems

Document control software

Jobbeschreibung

Pauwels Consulting seeks a Microbiology Expert – Small Molecules to support clinical and lifecycle management programs in a GMP-regulated environment. You will coordinate global microbiology activities and provide scientific input on method development, qualification, validation and transfer.

Fluent in English with 3+ years in pharma, you will lead cross-site microbiology projects, review validation docs, and ensure compliance with GMP/GxP standards while partnering with external and internal