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.
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