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.
