Lead Validation Engineer

Halian Technology; England; On-site; GBP 80,000 - 100,000; Full time

Job summary

A Medical Device company in the United Kingdom is seeking a Validation Engineer to join their Operations team in Suffolk. You will be responsible for ensuring the quality and compliance of medical devices through the development and execution of validation protocols. This role requires strong collaboration with cross-functional teams to support process improvements and compliance with regulatory standards. A background in validating manufacturing processes is essential for success in this position.

Qualifications

• Experience in validating manufacturing processes and equipment in a regulated environment.
• Strong knowledge of quality management systems and ISO standards.

Responsibilities

• Develop and document validation protocols and reports.
• Ensure compliance with regulatory standards.
• Collaborate with various teams to improve processes.
• Conduct risk assessments to ensure product quality.

Skills

Validation protocols development

Regulatory compliance knowledge

Risk assessment

Cross-functional collaboration

Job description

This is an exciting opportunity to join a Medical Device company with the manufacturing expertise to take new products through initial design and development through to high volume manufacture.

Due to expansion, a new role has been created for a highly skilled& experiencedValidation Engineer to jointhe Operationsteam inSuffolk.You will play a key role in ensuring the quality, safety, and compliance ofthe medical devicesproducedthrough the validation of manufacturing processes, equipment, and systems.

Key Responsibilities

Develop, execute, and document validation protocols and reports for manufacturing processes, equipment, cleaning, and sterilisation processes.

Ensure compliance with relevant regulatory standards such as ISO 13485,FDA andEU MDR.

Collaborate with cross-functional teams including Quality Assurance,R&D, Regulatoryand Manufacturing to support process improvements.

Conduct risk assessments and validation lifecycle activities to ensure product quality and manufacturing consistency.

Participate in audit preparations and suppor...