This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CSV Lead based in Spain.
This role offers an opportunity to lead Computer System Validation and compliance activities across complex pharmaceutical manufacturing environments.
You will provide validation leadership for computerized manufacturing and laboratory systems throughout their full lifecycle.
The position combines hands-on CSV expertise with risk management, documentation oversight, and regulatory compliance guidance.
You will partner closely with Quality, Engineering, Automation, IT/OT, laboratory, and project stakeholders.
Your expertise will help ensure systems remain compliant with GxP requirements and applicable regulatory expectations.
The role is well suited to an experienced validation professional who can work independently and confidently challenge project teams when needed.
You will contribute directly to the successful delivery of capital and strategic projects within a highly regulated industry.
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Accountabilities




Lead CSV and compliance activities for capital and strategic projects involving computerized manufacturing and laboratory systems.
Plan, execute, review, and approve validation lifecycle activities and documentation in accordance with GxP requirements, internal procedures, and regulatory expectations.
Provide expert guidance on CSV/CSA, SDLC, risk-based validation, system qualification, IQ/OQ/PQ, change control, configuration management, CAPA, deviations, and data integrity.
Conduct and review system risk assessments, define appropriate validation strategies, and ensure identified compliance risks have effective mitigation plans.
Maintain compliance oversight throughout system implementation, modification, operation, and retirement.
Collaborate with Quality, Engineering, Automation, IT/OT, laboratory, business, and project teams to integrate validation requirements throughout project delivery.
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📌 CSV Lead (España)
🏢 Jobgether
📍 España