Overview
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As Validation Engineer, you will lead validation activities for injection molding tools and processes, ensuring quality, safety and regulatory compliance across the lifecycle. You will partner with QA, R&D; and external partners to align validation strategies and document protocols. Your work supports GMP and ISO 13485 standards, tackling deviations, CAPAs and revalidations to maintain validated systems. This onsite role in Barcelona offers a chance to shape manufacturing quality in a global biomed/bioscience context. You will contribute to a culture of collaboration and continuous improvement, delivering robust evidence that underpins product quality and compliance.
Compensaciones / Incentivos
Meal voucher
Health Insurance (conditional to your role)
Bonus/Commission
Referral Program
Employee Assistance Program
Responsabilidades
Plan, execute and document validation activities (DQ, IQ, OQ, PQ) for injection molding tools, equipment and processes
Develop and maintain validation plans, protocols and reports in line with GMP and internal standards
Ensure regulatory compliance (ISO 13485, GMP)



throughout the product lifecycle
Manage revalidation activities and assess impact of technical changes on validated systems
Investigate deviations, non-conformities and OOS results with root cause analysis and CAPAs
Collaborate with QA, R&D; and external partners to align validation strategies
Review and approve technical documentation including specifications, risk analyses (FMEA) and change requests
Support audits and inspections with validation documentation and technical expertise
Requisitos principales
Degree in Engineering (e.g., Plastics, Mechanical, or Process xqbhyrx Engineering) or comparable technical qualification
Proven validation experience in a regulated environment (medical devices, pharma, life sciences)
Strong knowledge of validation principles, risk management and regulatory standards (ISO 13485, GMP)
Experience with manufacturing processes, ideally injection molding or plastics technologies
Familiarity with statistical methods and validation tools is advantageous
Fluent English; German is a plus
cross-functional collaboration
problem-solving
attention to detail
validation (DQ/IQ/OQ/PQ)
CAPA
FMEA

📌 Validation Engineer (Barcelona)
🏢 Qiagen
📍 Barcelona