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validation engineer jobs near nyon vd

Process Validation Engineer

Skillhubs
Genève, GE

Postuler rapidement

Détails de l'emploi

CDI | 100%

Qualifications

Français
Ingénierie mécanique
Anglais
Production
Compétences en communication
Connaissances en mécanique
ISO 13485

Description complète du poste

For one of our clients, an international medtech company, we are looking for a Process Validation Engineer to join the Quality & Regulatory organization.

This role focuses on qualification and validation activities for manufacturing processes.

Context

You will join the Quality & Regulatory organization and contribute to the qualification and validation strategy for internal and external manufacturing processes. Working closely with R&D, Operations, Regulatory Affairs, Production, Engineering, suppliers and subcontractors, you will ensure that manufacturing processes are robust, compliant and inspection-ready.

Responsibilities

As Process Validation Engineer, you will:

Act as Subject Matter Expert for Additive Manufacturing in a medical device environment.
Manage qualification and validation activities for additive manufacturing processes.
Coordinate and execute IQ/OQ/PQ activities for equipment, utilities and manufacturing systems.
Support process qualification, requalification and validation lifecycle activities.
Lead investigations, root cause analysis, CAPA and non-conformity resolution.
Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820 and EU MDR 2017/745.
Create, review and approve SOPs, validation protocols, reports and audit-ready documentation.
Analyze quality metrics and identify continuous improvement opportunities.
Support DHF completeness and validation / verification activities.
Manage process changes and related impact assessments.
Collaborate with Production, Engineering, Regulatory Affairs, R&D, suppliers and subcontractors.

Required Profile

You have an engineering degree, ideally in Mechanical Engineering, with proven experience in validation and qualification processes within a regulated environment.

You bring at least 5 years of experience in additive manufacturing using metallic materials, ideally in medical devices, orthopaedics, spinal implants or implantable devices.

You also bring:

Strong knowledge of IQ/OQ/PQ, process validation and qualification methodologies.
Practical experience with ISO 13485, ISO 14971, 21 CFR Part 820 and EU MDR 2017/745.
Excellent technical writing skills for protocols, reports, SOPs and audit-ready records.
Strong communication skills with the ability to explain technical and regulatory topics clearly.
Ability to manage multiple validation projects under tight deadlines.
Pragmatic, structured and solution-oriented mindset.
Ability to challenge decisions that may impact patient safety or regulatory compliance.
Fluent French and professional English.
Valid driving licence.

Preferred

Experience with subcontractors, external manufacturing partners, cleanroom systems or environmental monitoring is a plus. A Lean certification or demonstrated experience in Lean Manufacturing / continuous improvement is also preferred.

Work Location: Hybrid remote in Geneva, GE

Postuler rapidement

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validation engineer emplois - nyon vd

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Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : validation engineer (nyon vd)

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