CSV Lead - GMP Systems Validation

Position: CSV Lead – GMP Systems Validation

We are seeking a seasoned Computer System Validation (CSV) Lead with 5 to 10+ years of experience in GMP-regulated environments. The ideal candidate will have a strong track record of designing and executing end-to-end CSV strategies, including documentation frameworks, for complex systems supporting pharmaceutical or biotech operations.


KEY RESPONSIBILITIES

Strategy & Planning

• Develop and maintain a robust CSV Master Plan aligned with the overarching Validation Master Plan (VMP).
• Define system criticality, validation approaches per GAMP 5, and lifecycle management strategies for GMP systems.
  

System Inventory & Classification

• Establish and manage a comprehensive GxP system inventory, including GMP relevance, ownership, and audit readiness.
• Conduct system impact assessments to determine validation scope and depth.

Validation Execution

• Lead validation activities for Quality Management Systems (QMS), Data Acquisition Systems (SCADA, BMS, EMS), ERP platforms (SAP or equivalents), and analytical software (e.g., Waters HPLC, Labguru).
• Apply risk-based validation principles and tailor documentation based on system classification and criticality.

Compliance & Inspection Readiness

• Ensure alignment with GAMP 5, Annex 11, and 21 CFR Part 11 requirements.
• Provide expert support during facility startup and regulatory inspections.
  

Cross-Functional Collaboration

• Work closely with Quality Assurance, IT, and business stakeholders to ensure compliant and efficient validation strategies.
• Promote continuous improvement in CSV processes and documentation in line with evolving regulations and industry best practices.

CANDIDATE PROFILE

• 5–10+ years of CSV experience in GMP-compliant environments.
• Proven ability to build and implement CSV strategies from the ground up.
• Hands-on expertise in validating QMS, SCADA/BMS/EMS, ERP systems (SAP or similar), and analytical software.
• In-depth knowledge of GAMP 5, Annex 11, and 21 CFR Part 11.
• Experience supporting facility startups and inspection readiness.
• Strong skills in system inventory management and impact assessment.
• Advanced understanding of scalable, risk-based validation approaches.

This is a 1 year full-time contract of 40 hours per week, with likely possibility of extension or a switch to a permanent contract at the completion of the assignment. This role is suited to both freelancers and payrolled employees.

If you believe to be a suitable fit for the role, we would love to hear from you! If interested, please apply to this job advert or send a copy of your CV to davide.garello@nesfircroft.com.

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.