Regulated Validation Engineer – ISO/FDA Projects

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

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.