Experteer Overview
Desplácese hacia abajo para ver todos los requisitos del puesto y las responsabilidades que pueden esperar los candidatos seleccionados.
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, Ru0026amp;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 / Beneficios
• 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, Ru0026D 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
Responsabilidades
• Degree in Engineering (e.g., Plastics, Mechanical, or Process Engineering) or comparable technical qualification
• Proven validation experience xqbhyrx 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
Requisitos principales
• Meal voucher
• Health Insurance (conditional to your role)
• Bonus/Commission
• Referral Program
• Employee Assistance Program
or continue with email
Desplácese hacia abajo para ver todos los requisitos del puesto y las responsabilidades que pueden esperar los candidatos seleccionados.
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, Ru0026amp;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 / Beneficios
• 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, Ru0026D 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
Responsabilidades
• Degree in Engineering (e.g., Plastics, Mechanical, or Process Engineering) or comparable technical qualification
• Proven validation experience xqbhyrx 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
Requisitos principales
• Meal voucher
• Health Insurance (conditional to your role)
• Bonus/Commission
• Referral Program
• Employee Assistance Program
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