Associate Validation Engineer

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

The 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.

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.