Entry-Level Validation Engineer, Sterilization & QA

Sotera Health Company; Somercotes CP; On-site; GBP 50,000 - 70,000; 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 an Associate Validation Engineer to join the Quality team at the Somercotes facility on a permanent basis. The role focuses on planning, coordinating, and executing validation activities across customer, facility and research projects in a highly regulated environment.

You will collaborate with Operations, Engineering, Quality, Customer Service and external customers to ensure validation programmes are delivered efficiently, accurately and in compliance with regulatory

Qualifications

• Experience in a regulated industry such as Medical Devices, Pharmaceuticals, Life Sciences or Sterilisation Services.
• Experience writing and executing validation protocols.
• Ability to work in operational areas and handle validation samples/equipment.
• Knowledge of Quality Management Systems.
• Excellent organisational skills.
• Strong written and verbal communication skills.
• Good IT skills, including data analysis and report writing.

Responsibilities

• Review customer and EAS-supplied validation and test protocols for feasibility and compliance with Sterigenics procedures and regulatory requirements.
• Prepare and support the development of validation protocols, reports and associated technical documentation.
• Coordinate and execute validation studies, including scheduling validation activities, processing runs, laboratory testing and sample management activities.
• Collect, organise and analyse validation data to support project objectives and regulatory requirements.
• Prepare validation work instructions and supporting documentation for validation, production and laboratory personnel.
• Support validation calibration activities and annual equipment requalification programmes.
• Carry out hands-on validation activities within operational areas, including preparation, movement, inspection and handling of validation materials, samples and equipment.
• Maintain accurate, compliant validation records and update validation status within relevant systems.
• Assist with validation investigations, corrective actions and continuous improvement initiatives.
• Support Engineering and Maintenance teams with equipment qualification activities, including IQ, OQ and PQ protocols.
• Collaborate with internal departments and external customers to support successful project delivery.

Skills

Validation protocols writing

Organisational skills

Written and verbal communication

IT/data analysis

Job description

Sotera Health is seeking an Associate Validation Engineer to join the Quality team at the Somercotes facility on a permanent basis. The role focuses on planning, coordinating, and executing validation activities across customer, facility and research projects in a highly regulated environment.

You will collaborate with Operations, Engineering, Quality, Customer Service and external customers to ensure validation programmes are delivered efficiently, accurately and in compliance with regulatory