Validation Engineer

Sterigenics; Somercotes CP; On-site; GBP 35,000 - 55,000; Full time

Benefits offered by this job

34 days holiday (26 + 8 Bank Holiday)

Medicash Health Plan

Company pension scheme

Life Assurance – cover of 4x annual薪

Employee Assistance Programme (EAP)

Cycle to work scheme

Job summary

Sterigenics is seeking a Validation Engineer to join the Quality team at our Somercotes facility on a 12-month fixed-term contract. Reporting to the QA Manager, you will lead validation activities in a highly regulated environment, ensuring compliance with ISO standards and FDA regulations.

You will plan, execute, and document validation studies across multiple functions, write protocols and reports, and act as a technical contact for customers and internal stakeholders.

Qualifications

• Experience in a regulated industry such as Medical Devices or Pharmaceuticals.
• Experience writing and executing validation protocols.
• Knowledge of Quality Management Systems and validation principles.
• Strong analytical and problem-solving abilities.
• Excellent organisational and 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 for compliance and feasibility.
• Execute validation studies including processing runs, lab testing and sample management.
• Collect, analyse and interpret validation data.
• Support equipment qualification activities (IQ/OQ/PQ).
• Ensure calibration activities align with the QA system and standards.
• Maintain accurate validation records and documentation.
• Lead improvement projects to enhance efficiency and reduce deficiencies.
• Act as a technical contact for customers and internal stakeholders.

Skills

Regulated industry experience

Validation protocols

Quality Management Systems

Analytical skills

Organisational skills

Communication skills

Data analysis

Job description

About You

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. 12-Month Fixed-Term Contract. Make a Difference in Healthcare. 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 a Validation Engineer to join our Quality team at our Somercotes facility on a 12-month fixed-term contract. This role offers an exciting opportunity to 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 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

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.