Senior CSV Consultant

Company Description

GMP Bridge is a boutique consultancy specializing in guiding biotech, biopharma, and advanced therapy companies through complex GMP and Quality challenges. With a focus on critical operational areas like sterile manufacturing, clinical-to-commercial transitions, and CDMO oversight, GMP Bridge provides targeted expertise to ensure sustainable compliance and operational excellence. The consultancy is trusted across Europe, North America and Asia, offering senior-level consultants with over 20 years of GxP experience.

Role Description

This is a short-term remote freelance engagement for a Senior CSV Consultant to support a biopharma client in Germany as part of an ongoing FDA/EMA Inspection Readiness program that GMP Bridge has been running for over a year. The consultant will work alongside our existing team to create, complete, and close CSV documentation for laboratory and QC systems. The role requires someone who can work hands-on and independently, with strong practical judgment on what constitutes a GMP- and Data Integrity-defensible validation package.

Qualifications

• Strong hands-on CSV experience in GxP-regulated environments
• Experience with laboratory and QC systems, preferably stand-alone or semi-stand-alone lab instruments
• Solid knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11, and current Data Integrity expectations
• Proven ability to draft and finalize CSV documents: URS, FS, CS, Risk Assessment, OQ Plan, OQ Protocol
• Practical judgment to define "where the bar is" — avoiding over-validation while remaining inspection-defensible
• Ability to work remotely and independently with minimal supervision
• Comfortable working in English across all documentation and stakeholder communication
• Freelance setup or own company required — candidates based in Europe preferred

To apply, please send your expression of interest to contact@gmpbridge.com indicating your current availability, weekly capacity, and hourly rate range.

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