Validation Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As a Validation Engineer at our Newport site, you will:

Validation Leadership

• Develop and implement the site validation program for products, processes, equipment, software, and test methods, ensuring compliance with ISO 13485 and IVDR standards.

• Lead test method validation initiatives to enhance inspection accuracy and reliability.

Problem-Solving & Quality Improvement

• Perform root cause analysis and implement corrective actions for process-related issues, driving continuous improvement across operations.

• Champion quality system enhancements through methodologies like Six Sigma, 5S, and Lean Manufacturing, fostering a culture of operational excellence.

• Lead technical quality training programs to upskill teams in areas like risk management (ISO 14971), validation, statistical techniques, and RCA methodologies.

• Facilitate timely and effective resolution of customer complaints, supplier deficiencies, and quality concerns, ensuring customer satisfaction.

Multi-functional Collaboration

• Partner with Engineering and Operations to ensure seamless transfer of new products to production, meeting customer and regulatory expectations.

• Work closely with suppliers and customers to address complaints, investigate failures, and ensure robust closure

Compliance & Auditing

• Conduct internal and external audits, addressing findings with thorough reports and actionable corrective/preventive measures.

• Drive compliance and enhance quality systems in alignment with regulatory and customer requirements.

Minimum Requirements/Qualifications:

• Bachelor’s degree in Science or Engineering

• Excellent problem solving and analytical skills and developed understanding of risk management

• Excellent oral and written communication skills

• Excellent digital literacy

• Ability to work independently and proactively

• Demonstrated leadership ability

• Experience in Medical Devices (PFMEA, Control Plan, CAPA)

• Solid understanding of ISO 9001 and ISO 1348

• Experience working in a GMP environment such as Medical Device industry or plastic consumables

• Statistical Analysis Tools such as Minitab or JMP, SAP, TrackWise, Microsoft Excel, Visio, Power Point, and MS Project

The company is as equal opportunity business committed to fairness and diversity in hiring!

Company Benefits

Access to company stock purchase scheme

Holiday purchase program

Pension Scheme

Medical Benefit Options

Group Income Protection cover

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.