Lead Validation Engineer

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

Job summary

A Medical Device company in Exeter is seeking an experienced Validation Engineer to ensure the quality, safety, and compliance of medical devices. Responsibilities include developing validation protocols, ensuring adherence to ISO 13485 and FDA standards, and collaborating with various teams for process improvements. Applicants should possess a bachelor's degree in engineering or life sciences, with a minimum of 5 years' experience in process validation. The role offers competitive compensation and the chance to work independently and as part of a team.

Qualifications

• Minimum of 5 years of experience in process validation within the medical device manufacturing industry.
• Strong understanding of validation lifecycle and methodologies.
• Data driven with experience using statistical software.

Responsibilities

• Develop, execute, and document validation protocols and reports.
• Ensure compliance with regulatory standards.
• Collaborate with cross-functional teams for process improvements.
• Conduct risk assessments and validation lifecycle activities.

Skills

Validation methodologies (IQ/OQ/PQ)

Regulatory knowledge (ISO 13485, FDA, EU MDR)

Risk management tools

Statistical software

Problem-solving

Communication skills

Organisational skills

Team collaboration

Education

Bachelors degree in engineering or life sciences

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 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 and EU 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

Job Overview

• ID: 1864220
• Date Posted: Posted 1 day ago
• Expiration Date: 06/02/2026
• Location: Exeter
• Competitive