🇪🇸 Spain · 14h ago
CSV Lead
Jobgether
LinkedInleadEnglish-friendly
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.AccountabilitiesLead 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.Support regulatory inspections, internal audits, remediation initiatives, and other compliance activities when required.Promote consistent, risk-based CSV/CSA practices across manufacturing projects and computerized systems.Contribute validation and qualification expertise across systems such as DeltaV Distributed Control Systems, Rockwell or Siemens PLCs, process historians, laboratory automation, and other GxP-regulated manufacturing platforms.Requirements5+ years of professional experience, with strong hands-on Computer System Validation experience in GMP-regulated pharmaceutical or manufacturing environments.Demonstrated experience supporting validation and compliance activities for computerized manufacturing systems.Strong knowledge of validation lifecycle management, CSV/CSA principles, GxP/GMP requirements, SDLC, IQ/OQ/PQ, change control, CAPA, deviation management, risk-based validation, risk management, and data integrity.Proven ability to develop, review, and approve validation documentation and other compliance deliverables.Understanding of FDA, EMA, and international regulatory expectations applicable to computerized systems in regulated environments.Ability to independently assess compliance risks, define practical solutions, and provide guidance or constructive challenge to project teams.Experience with manufacturing automation or IT/OT environments, with exposure to platforms such as DeltaV, Rockwell or Siemens PLCs, process historians, or laboratory automation highly desirable.Previous experience as a CSV Lead, Validation Lead, or senior compliance representative on complex manufacturing or pharmaceutical projects is preferred.Familiarity with modern Computer Software Assurance and risk-based validation approaches.Strong stakeholder-management, communication, leadership, and problem-solving skills, with the ability to work effectively across international and cross-functional teams.Professional fluency in English and the ability to operate autonomously in a remote environment.BenefitsFreelance / contract engagement.Full-time allocation of approximately 40 hours per week.Expected start date: September 2026.Opportunity to contribute to major pharmaceutical manufacturing and capital projects.Exposure to complex GxP-regulated systems, validation programs, and international compliance requirements.Opportunity to work across multidisciplinary teams spanning Quality, Engineering, Automation, IT/OT, laboratory, and project functions.How Jobgether WorksWe use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.We appreciate your interest and wish you the best! Why Apply Through Jobgether?Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.Sourced from LinkedIn. Relocantly aggregates public job postings; apply on the original site.