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CSV Lead

4 weeks ago

United Kingdom Blackfield Associates Full time

Blackfield Associates have collaborated with the lead developer of critical manufacturing management systems for advanced therapies in search for a full time remote CSV Lead.


About the company:

  • Our client company is founded by Cell and Gene Therapy (CGT)
  • This company is creating a portfolio of software solutions such as electronic Batch Manufacturing Records (eBMR)
  • They provide cell and gene therapy manufacturers with methods to scale their operations
  • Their mission is to make medicine deliverable, available, and affordable.


Responsibilities include:

  • Develop, implement, and oversee the risk-based Computer System Validation (CSV) strategy for deploying the company's main paper-based computer system
  • Provide expert guidance to ensure business compliance with CSV standards, 21 CFR Part 11, and Eudralex Annex 11 regulatory requirements.
  • Prepare documentation in alignment with the V-Model approach outlined in GAMP 5.
  • Serve as a subject matter expert (SME) in CSV and data integrity for client projects, managing associated budgets effectively.
  • Create, review, and execute validation lifecycle deliverables following the V-Model within GAMP 5 and GxP Good Practices.
  • Lead investigations into validation-related non-conformances to identify and address root causes.
  • Assist the project management team in maintaining and managing validation timelines.
  • Advise on GxP compliance and industry best practices.
  • Collaborate with stakeholders, including IT and Quality teams, to track progress and ensure successful completion of validation activities.


Desired criteria:

  • Hold a relevant degree in a scientific or technical discipline.
  • Demonstrate the ability to clearly and concisely articulate system integrations.
  • Possess experience with Quality Management Systems (QMS) in pharmaceutical and/or clinical environments.
  • Exhibit a strong eagerness to learn continuously and embraces knowledge beyond a single area of expertise.
  • Effectively explain and communicate complex system behaviours with clarity and precision.
  • Excel in both collaborative team settings and independent work, maintaining strong organisational skills and self-motivation.


Additional benefits:

  • Join quarterly social events, whether it’s team-building exercises, dinners, or simply unwinding with a drink or two.
  • Benefit from market-competitive salaries with regular pay reviews to recognize and reward great work.
  • Receive top-of-the-line equipment for your home office setup to maximise productivity.
  • If desired, able to utilise the London office near Oxford street
  • Access to BUPA healthcare
  • Pension matched to 3% and then an increase to 5% after probation completion
  • Life insurance