Senior CSV Specialist

We are seeking a Senior CSV Consultant to lead validation activities across a broad scope of systems. This role sits within the technical operations function, which covers new product introduction, CQV, CSV, automation, and supporting services. The consultant will act as the internal lead for computer system validation, coordinating external consultants and ensuring compliance across all digital deployments.

Key Responsibilities

• Lead CSV strategy and execution for site‑wide digital systems, including EMS, LIMS, manufacturing, facility, and utility systems
• Provide decision‑making support and orientation for CSV activities, ensuring alignment with regulatory expectations (EU GMP, GAMP, EudraLex)
• Coordinate and oversee junior consultants and external partners, ensuring quality and timely delivery of validation activities
• Act as the internal CSV lead within Tech Ops, bridging across CQV, automation, and new product introduction teams
• Support remediation plans and proactively resolve validation or compliance issues
• Collaborate cross‑functionally with QA, QC, Manufacturing, Engineering, and IT to ensure seamless system deployment and integration
• Drive a culture of ownership, accountability, and quality mindset across validation activities

Essential Skills & Experience

• Proven expertise in Computer System Validation (CSV), including strategy development, execution, and oversight
• Strong quality mindset with the ability to identify, troubleshoot, and resolve compliance challenges
• Experience in automation system validation as well as CSV
• Solid understanding of GMP regulations, GAMP guidelines, and EudraLex requirements
• Demonstrated ability to coordinate teams, mentor junior consultants, and manage multiple stakeholders
• Excellent interpersonal and communication skills, with the ability to work across diverse departments

Desirable Skills

• Background in automation engineering
• Experience working in an international, English‑speaking environment (French language skills advantageous)
• Knowledge of OT and manufacturing systems, with exposure from QC labs through to large‑scale production

Qualifications

• Minimum BSc or Engineering degree in a relevant discipline (e.g., Engineering, Life Sciences, Computer Science).