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
