10+ years across multinational pharma and emerging biotech in Europe:

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EU GMP Annex 1 & Compliance:

• Gap assessments, CCS development, rapid remediation sprints

• PUPSIT implementation and filter integrity testing validation

• Development of new sterile filtration line 

• Annex 1 Gap Analyses: Successfully defended before authorities for Fill-Finish projects

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Capital Projects:

• Multi-million dollar sterile filtration line (design development)

• RABS optimization and aseptic process redesign

• Cleanroom design and contamination control strategies

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From startup agility to corporate scale all projects delivered in GMP regulated environments with focus on practical implementation and regulatory defensibility.