Senior Process Validation Engineer – MedTech & Global

Abbott AG; Zürich; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Abbott AG in Zürich seeks a Senior Technical Specialist for Process Validation to shape validation across MVP/MVR, IQ/OQ/PQ, and SPV. You will document protocols, supervise floor validations, and collaborate with suppliers to ensure regulatory compliance and product quality.

The role requires a Master’s or higher in engineering, 5+ years in Med-Tech, and fluency in English. Expect close interaction with teams in Switzerland and the USA within a 100% on-site role.

Qualifikationen

• Master’s or Bachelor’s degree in relevant engineering field.
• 5+ years in med-tech with process validation and regulatory knowledge.
• Strong knowledge of ISO 13485, FDA 21CFR820, MDR and GMP guidelines.
• Experience with risk analysis, TMV/IMV and IQ/OQ/PQ validation.

Aufgaben

• Accountable for validation planning and execution across MVP/MVR, IQ, OQ, PQ, PPQ and SPV.
• Create and maintain validation docs, protocols and reports.
• Maintain presence on the manufacturing floor to validate processes and drive improvements.
• Lead TMV/IMV validation and support pFMEA updates.
• Support CAPA/NCMR investigations and supplier QA activities (SCAR/SCR).
• Collaborate with suppliers on quality topics and change requests.
• Propose new technologies to improve quality, efficiency, and compliance.
• Drive ongoing OPEX improvements and participate in audits as SME.

Kenntnisse

FMEA risk analysis

TMV/IMV validation

IQ/OQ/PQ

Statistical methods

Minitab

Microsoft Office

Power BI

SAP ERP

Windchill PLM

SolidWorks CAD

ISO 14971:2019

Six Sigma Black Belt

Project management

Ausbildung

Master’s degree in Electrical Engineering

Bachelor’s degree in Mechanical/Industrial Engineering

Tools

SAP ERP

Windchill PLM

SolidWorks CAD

Jobbeschreibung

Abbott AG in Zürich seeks a Senior Technical Specialist for Process Validation to shape validation across MVP/MVR, IQ/OQ/PQ, and SPV. You will document protocols, supervise floor validations, and collaborate with suppliers to ensure regulatory compliance and product quality.

The role requires a Master’s or higher in engineering, 5+ years in Med-Tech, and fluency in English. Expect close interaction with teams in Switzerland and the USA within a 100% on-site role.