Lead Validation Engineer

Job Overview

Date Posted:
Posted 1 day ago

Expiration Date: 06/02/2026

Location:

Maidstone

Competitive

• 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.

• Bachelor's degree in engineering, life sciences or a related field (Chemical, Mechanical Engineering).
• Minimum of 5 years' experience in process validation 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.

• 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.