Senior Technical Specialist - Process Validation

Abbott AG; Zürich; On-site; CHF 120,000 - 170,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

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

Education

Master’s degree in Electrical Engineering

Bachelor’s degree in Mechanical/Industrial Engineering

Tools

SAP ERP

Windchill PLM

SolidWorks CAD

Job description

Senior Technical Specialist - Process Validation

Abbott AG Vacant since : 06.11.2026 8005 Zürich (ZH) 100% By agreement Permanent

Shape the Future of Mechanical Circulatory Support

Join Abbott's Heart Failure business and play a key role in bringing the next generation of Circulatory Support Systems from development into global manufacturing.

Become part of a great team which is responsible for establishing and maintaining processes along the entire supply chain and manufacturing of life-supporting medical devices which are based on the fascinating technology of magnetic levitation. With your work you’ll ensure our products and processes meet the high standards of our industry and are inline with our policy "built as intended for your family". In your role you will be interfacing and collaborating with cross-functional teams in Switzerland and the USA.

MAIN RESPONSIBILITIES

• Accountable for process validation planning and execution including supplier process validations, e.g. Master Validation Planning (MVP/MVR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ) and Supplier Process Validation (SPV)
• Creation and maintenance of validation documentation, e.g. validation protocols, validation reports and supporting documentation such as change orders, risk analysis, deviation reports, etc.
• Maintain a strong presence on the manufacturing floor, working directly with processes, equipment, and operators to execute validations, investigate issues, verify process performance, and drive practical, data-driven improvements
• Lead Test and Inspection Method Validation activities (TMV/IMV) Support risk management activities such as process Failure Mode and Effects Analysis updates (pFMEAs)
• Support CAPA or nonconforming material (NCMR) related investigation or validation activities
• Work closely with suppliers of electronic and mechanical parts on manufacturing and quality topics such as Supplier Corrective and Preventive Actions (SCAR's) and Supplier Change Requests (SCR's)
• Propose new or improved technologies and processes to enhance product quality, manufacturing efficiencies, cost, and regulatory compliance
• Drive continuous and measurable improvements OPEX (Operational Excellence)
• Participate in internal and external audits as SME for process validation

THE PROFILE

• Master’s degree/bachelor’s in electrical engineering, Mechanical Engineering, Industrial Engineering or similar (ETH/FH or comparable education)
• 5 years or more of experience in a similar position in Med-Tech industry Detailed knowledge of medical standards like ISO 13485, FDA 21CFR820, ISO 14971, IEC 60601-1, MDSAP, GMP, GDP, IMRDF (GHTF)
• Proven expertise in EU MDR regulations and cross-functional department coordination. Leading MDR-related projects will be considered a plus.
• Proven expertise in risk analysis (FMEA), process and test method validation (TMV/IMV, IQ/OQ/PQ)
• Detailed knowledge of statistical methods, techniques, and software tools to analyze data such as Minitab
• Experience in manufacturing of electronic or Electromechanical products is a plus, Knowledge of SAP (ERP system), Windchill (PLM and Change Order system), Solid Works (CAD), Power BI is a plus
• Experience in EUMDR Class III and Class II Medical devices submissions, Obsolescence Management and Various Manufacturing Process (Injection molding) considered a plus
• Technical Project Management: Ability to lead smaller Project independently
• English Level C2 is required, language skills are considered a plus
• Flexible team player with accurate working and documentation style
• Excellent analytical and creative problem-solving skills and process thinking
• Proficient in Microsoft applications (PowerPoint, Word, Excel, Visio)
• Risk management activities according to ISO 14971:2019, certification is a plus
• Black belt six sigma certification is required

Why Join Abbott?

• Make a direct impact on technologies that help save and improve patients' lives.
• Lead critical industrialization activities for a next-generation circulatory support platform.
• Collaborate within a truly global team spanning Zurich, Switzerland and Pleasanton, California.
• Influence both product design and manufacturing strategy early in the development process.
• Work with advanced electromechanical medical technology in a highly innovative environment.
• Grow your career within one of the world's leading healthcare companies.

The Best of Both Worlds

Our Zurich Heart Failure site is home to approximately 160 employees, offering the visibility, ownership, agility, and family-like culture often associated with a smaller organization. Here, you can see the direct impact of your work, build strong cross-functional relationships, and influence key decisions.

At the same time, you will be part of Abbott's global organization, collaborating closely with teams in Pleasanton, California and around the world while benefiting from the resources, stability, technology leadership, and career opportunities of one of the world's leading healthcare companies.

• Work location 8005 Zürich (ZH)
• Workload 100%
• Employment start By agreement
• Employment duration Permanent
• By online Online form

• Abbott AG
  Technoparkstrass 1
  8005 Zürich