Validation Engineer - Medical Devices (12-Month Contract)

Sotera Health Company; Somercotes CP; On-site; GBP 42,000 - 54,000; Full time

Benefits offered by this job

34 days holiday (26 + 8 Bank Holiday)

Medicash Health Plan

Company pension scheme

Life Assurance – 4x annual salary

Employee Assistance Programme (EAP)

Cycle to work scheme

Job summary

Sotera Health is seeking a Validation Engineer for the Somercotes facility on a 12-month fixed-term contract. You will support customer validation projects, ensure compliance with ISO standards and FDA regulations, and collaborate across Operations, Engineering, Sales and Quality.

Reporting to the Quality Assurance Manager, you will plan, execute and document validation programmes, lead improvement projects and act as a technical contact for customers and internal stakeholders.

Qualifications

• Experience in regulated industries such as Medical Devices, Pharmaceuticals, Life Sciences, Healthcare or Sterilisation Services.
• Experience writing and executing validation protocols.
• Knowledge of Quality Management Systems and validation principles.
• Strong analytical and problem-solving skills.
• Excellent organisational skills with the ability to manage multiple priorities.
• Strong written and verbal communication skills.
• Good IT skills, including data analysis and report writing.

Responsibilities

• Plan, coordinate and manage customer validation projects from initiation through to completion.
• Write validation protocols, reports and supporting technical documentation.
• Review customer-supplied validation protocols to ensure compliance and operational feasibility.
• Execute validation studies, including scheduling processing runs, laboratory testing and sample management activities.
• Collect, analyse and interpret validation data.
• Support equipment qualification activities, including IQ, OQ and PQ protocols.
• Ensure calibration activities are performed in accordance with the Quality Management System and relevant standards.
• Maintain accurate and compliant validation records and documentation.
• Lead improvement projects to enhance efficiency and reduce process deficiencies.
• Act as a technical contact for customers and internal stakeholders on validation-related matters.

Skills

Validation protocols

Regulated industry experience

Analytical skills

Documentation

Communication

Job description

Sotera Health is seeking a Validation Engineer for the Somercotes facility on a 12-month fixed-term contract. You will support customer validation projects, ensure compliance with ISO standards and FDA regulations, and collaborate across Operations, Engineering, Sales and Quality.

Reporting to the Quality Assurance Manager, you will plan, execute and document validation programmes, lead improvement projects and act as a technical contact for customers and internal stakeholders.