Validation Engineer

Validation Engineer

About the Role

We are currently seeking a Validation Engineer to join our Quality team at our Somercotes facility on a 12-month fixed-term contract.

Reporting to the Quality Assurance Manager, the Validation Engineer serves as the facility's technical representative for validation activities, ensuring compliance with ISO standards, FDA regulations and customer requirements. You will work across multiple functions including Operations, Engineering, Sales, Quality and external customers to successfully plan, execute and document validation programmes.

Key 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 Sterigenics 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.

• About You

• Essential Requirements

• Experience working within a regulated industry 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.

• Desirable

• Experience in sterilisation validation.

• Knowledge of FDA and ISO regulatory requirements.

• Experience supporting equipment qualification projects.

Benefits

• 34 days holiday (26 + 8 Bank Holiday Allowance)

• Medicash Health Plan

• Company pension scheme

• Life Assurance – cover of 4 times your annual salary

• Employee Assistance Programme (EAP)

• Cycle to work scheme