Lead Validation Engineer

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

Job summary

A leading technology company located in Maidstone is seeking a qualified individual for a role focused on process validation within the medical device manufacturing industry. The ideal candidate will have at least 5 years of experience, a Bachelor’s degree in engineering or life sciences, and a solid understanding of regulatory standards such as ISO 13485 and FDA regulations. This position involves developing, executing, and documenting validation protocols while collaborating with cross-functional teams to ensure compliance and product quality.

Qualifications

• 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).

Responsibilities

• Develop, execute, and document validation protocols for manufacturing processes.
• Ensure compliance with regulatory standards such as ISO 13485 and FDA.
• Collaborate with cross-functional teams to support process improvements.
• Conduct risk assessments to ensure product quality.

Skills

Process validation

Regulatory compliance

Risk management

Statistical analysis

Problem-solving

Education

Bachelor's degree in engineering or life sciences

Job description

Job Overview

ID: 1864805

Date Posted: Posted 1 day ago

Expiration Date: 06/02/2026

Location: Maidstone

Competitive

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

• 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.

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.