Process Engineer

Overview

We are seeking an experienced Process Engineer to support validation activities within a regulated medical device manufacturing environment. The successful candidate will play a key role in ensuring manufacturing processes are validated, compliant, and capable of consistently producing high-quality products.

Key Responsibilities

• Lead and support process validation activities, including protocol development, execution, and reporting.
• Perform IQ, OQ, and PQ activities for manufacturing processes and equipment.
• Analyse validation data and provide recommendations for process improvements.
• Ensure compliance with internal quality standards and regulatory requirements.
• Collaborate with Manufacturing, Quality, Engineering, and Operations teams on validation projects.
• Support process optimisation, troubleshooting, and continuous improvement initiatives.
• Maintain accurate validation documentation and technical reports.
• Participate in audits and support regulatory inspections where required.

Required Experience

• Proven experience in Process Validation within the Medical Device industry.
• Strong understanding of validation lifecycle methodologies and statistical analysis.
• Experience working within highly regulated manufacturing environments.
• Knowledge of electronic validation management systems, including ValGenesis or similar validation software.
• Familiarity with established validation procedures, documentation standards, and change control processes commonly used within large-scale medical device organisations.
• Experience supporting product transfers, new product introductions (NPI), or manufacturing process improvements is advantageous.