Associate Validation Engineer

Sotera Health Company; Somercotes CP; Remote; GBP 38,000 - 52,000; Full time

Benefits offered by this job

34 days holiday

Medicash Health Plan

Company pension scheme

Life Assurance – 4x annual salary

Employee Assistance Programme (EAP)

Cycle to work scheme

Job summary

Sotera Health Company is seeking an Associate Validation Engineer to join the Somercotes facility on a permanent basis. You will support validation activities across customer, facility and research projects, collaborating with Operations, Engineering and Quality teams to ensure compliant delivery.

The role provides exposure to validation programs, quality systems and equipment qualification in a highly regulated environment.

Qualifications

• Experience in regulated Medical Devices, Pharmaceuticals, Life Sciences, Healthcare or Sterilisation Services.
• Experience writing and executing validation protocols.
• Ability to perform hands-on validation in operational areas and handle validation samples and equipment.
• Knowledge of Quality Management Systems and regulatory expectations.
• Excellent organisational and documentation skills; strong written and verbal communication.
• Proficiency with IT tools for data analysis and report writing.

Responsibilities

• Review validation protocols for feasibility and regulatory compliance.
• Prepare and support development of validation reports and technical documentation.
• Coordinate and execute validation studies, including scheduling and sample management.
• Collect, organise and analyse validation data to support objectives and regulatory requirements.
• Prepare validation work instructions and supporting documentation for personnel.
• Support calibration activities and annual equipment requalification programmes.
• Carry out hands-on validation activities within operational areas and handle materials and equipment.
• Maintain accurate, compliant validation records and update status in systems.
• Assist with validation investigations and continuous improvement initiatives.
• Support IQ, OQ and PQ protocols with Engineering/Maintenance teams.
• Collaborate with internal departments and external customers to ensure project delivery.

Skills

Regulated industry experience

Validation protocols writing

Operational validation

Quality Management Systems

Organisational skills

Communication skills

Data analysis

Job description

## Associate Validation EngineerApply: Somercotes: Full time: Posted Today: R-2026-1051The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health.Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.Sterigenics is a global leader in sterilisation services, helping to ensure the safety and effectiveness of medical devices and pharmaceutical products used around the world. We are currently seeking an Associate Validation Engineer to join our Quality team at our Somercotes facility on a permanent basis. This role offers an exciting opportunity to develop your validation expertise and work in a highly regulated environment, supporting customer validation projects, maintaining compliance with international standards, and contributing to continuous improvement initiatives. **About the Role**Reporting to the Quality Assurance Manager, the Associate Validation Engineer will support the planning, coordination and execution of validation activities across customer, facility and research projects. Working closely with Operations, Engineering, Quality, Customer Service and external customers, you will help ensure validation programmes are delivered efficiently, accurately and in compliance with regulatory and customer requirements.This role offers excellent exposure to validation, quality systems and equipment qualification activities, making it ideal for someone looking to develop their career within a regulated engineering or life sciences environment. **Key Responsibilities*** Review customer and EAS-supplied validation and test protocols for operational 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. **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.* Ability to undertake the practical and physical aspects of the role, including working within operational areas and handling validation samples, products and associated equipment.* Knowledge of Quality Management Systems* Excellent organisational skills* 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 Applicants must have the legal right to work in the UK. Please note that Sterigenics does not offer visa sponsorship for this position.