Experteer Overview
As a Validation Engineer at QIAGEN Barcelona, you will lead validation activities for injection molding tools and processes to ensure quality, safety, and regulatory compliance. You will collaborate with cross-functional teams to maintain GMP and ISO 13485 standards across the product lifecycle. You’ll develop plans, protocols, and reports while handling deviations, CAPAs, and revalidations to safeguard validated systems. This role offers meaningful impact by supporting scalable manufacturing in a global biotech environment. You will contribute to shaping reliable manufacturing capabilities that support life sciences breakthroughs.

Compensaciones / Ventajas
• Plan, execute, and document DQ/IQ/OQ/PQ validation for injection molding tools, equipment, and processes
• Develop and maintain validation plans, protocols, and reports aligned with GMP and internal quality standards
• Ensure regulatory compliance (ISO 13485, GMP) throughout the product lifecycle
• Manage revalidation activities and assess impact of changes on validated systems
• Investigate deviations, non-conformities,



and out-of-spec results; perform root cause analyses and implement CAPAs
• Collaborate with Quality Assurance, Ru0026D, and external partners on validation strategy
• Review and approve technical documentation including specifications, FMEA, and change requests
• Support audits and inspections by providing validation documentation and expertise

Responsabilidades
• Degree in Engineering or comparable technical qualification
• Proven experience in validation within a regulated environment (medical devices, pharmaceuticals, or 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 advantageous
• Fluent English; German is a plus

Requisitos principales
• Meal voucher
• Health Insurance (conditional to your role)
• Bonus/Commission
• Referral Program
• Employee Assist Ance Program

📌 Validation Engineer (Barcelona)
🏢 Qiagen
📍 Barcelona