Lead Validation Engineer

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& experienced

Validation Engineer to jointhe Operation steam in Suffolk.

You will play a key role in ensuring the quality, safety, and compliance ofthemedical 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, Regulatory and Manufacturing to support process improvements. Conduct risk assessments and validation lifecycle activities to ensure product quality and manufacturing consistency. Participate in audit preparations and support regulatory inspections related to validation activities.

Maintain validation documentation in accordance with regulatory and company requirements. Qualifications &

Experience:

Bachelors degree in engineering,life sciencesor a related field(Chemical, Mechanical Engineering) Minimum of 5years' experience inprocessvalidation within the medical device manufacturing industry. Strong understanding of validation methodologies (IQ/OQ/PQ) and validation lifecycle. Knowledge of regulatory standards (ISO 13485, FDA regulations, EU MDR).

Experience with risk management tools and techniques. Data driven, comfortable using statistical software. Excellent problem-solving, communication, and organisational skills. Ability to work independently and as part of a multidisciplinary team.

Preferred Qualifications:

Previous experience in a Process Validation role in a CMDO or medical device manufacturer working at volume Knowledge of the operation and constraints associated with high volume automation systems