Lab Compliance & Validation Lead

Preventx; Sheffield; On-site; GBP 40,000 - 56,000; Full time

Job summary

Preventx is seeking a Project Compliance Officer to validate laboratory analysers, assays, and operations systems, ensuring compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulations. The role is based at Head Office, Meadowhall, Sheffield, with an application closing date of 30 September 2026.

The post holder will support the Operations and Quality teams to maintain compliance and oversee validation activities across the laboratory network.

Qualifications

• Experience with ISO 15189/ISO 27001/ISO 9001/ISO 14001 and medical device regulatory frameworks.
• Strong analytical mindset with attention to detail and accuracy.
• Ability to perform validation and verification in a regulated lab environment.

Responsibilities

• Plan, write, and execute validation/verification protocols for new analysers, assays, and laboratory systems.
• Conduct validation studies: accuracy, precision, linearity, detection limits, measurement uncertainty, and reference interval verification.
• Document validation activities to meet ISO 15189 and internal QMS requirements.
• Lead IQ/OQ/PQ processes for equipment and software.
• Support operations to maintain ongoing accreditation compliance.
• Maintain validation records and equipment files per accreditation requirements.
• Participate in internal audits, external assessments, and CAPA processes.
• Support competency assessments and training related to new instruments and assays.
• Contribute to compliance efforts across ISO 27001, ISO 9001, and ISO 14001.

Job description

Preventx is seeking a Project Compliance Officer to validate laboratory analysers, assays, and operations systems, ensuring compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulations. The role is based at Head Office, Meadowhall, Sheffield, with an application closing date of 30 September 2026.

The post holder will support the Operations and Quality teams to maintain compliance and oversee validation activities across the laboratory network.