CSV Specialist

This is an opportunity working as a Senior CSV Specialist to support a brand-new facility who are moving into commercial manufacturing this year.

You will be responsible for generating and executing validation documentation compliant to GMP and industry regulations to validate computer systems in a biopharmaceutical manufacturing plant.

This role will offer you:

• To take ownership of GxP computer systems compliance for a global business
• To act as their CSV subject matter expert in senior leadership meetings
• To be part of a dynamic, supportive, and collaborative environment where your growth and development will be a priority.
• To lead transformative projects, shape the future of biomanufacturing, and contribute to producing medicines that truly improve lives.
• The opportunity for significant growth within a pioneering, global biopharma company.

You will be responsible for:

• Providing leadership and support to the company with regards to CSV GxP compliance
• Taking part in leadership meetings acting as the CSV SME - Providing expert input to support Operations, Qualification and Validation SOPs
• Validation and qualification documentation for computer systems
• Reporting progress to SLT and internal customers to ensure validation activities are aligned with other cross-functional departments

You will bring the following:

• Extensive CSV GxP quality assurance experience
• Strong working experience within a GMP and GLP regulated environment
• Knowledge of CFR 21 Part 11, GAMP 5 and Data Integrity
• Bachelor's degree in a relevant Life Sciences subject
• French and English