Process Engineer / Validation Engineer, Medical Device

Process Engineer / Validation Engineer, Medical Device

Location: Coventry
Type: Permanent role
Hours: Monday to Friday (days), flexible hours & potential for early finish on a Friday
Salary: Very competitive (open to discussion on this)
Additional: 25+ BH holidays, income protection, life insurance, enhanced pension scheme

Our client, a global medical devices company, is looking to appoint a Process Engineer (PE) to work at their modern manufacturing facility in Coventry. Reporting to the Process Engineering Manager (PEM), the PE will be responsible for developing and implementing process strategies, managing process resources, optimizing current processes, and maintaining process documents.
The role is a hands-on role (mainly on the production floor) and involves working within a clean-room environment (class/grade 8) and other parts of the facility too (various equipment).

The Role:

1. Preparing process documentation and operating instructions
2. Overseeing and assessing new and existing processes and workflows
3. Meeting with production managers to assess existing processes
4. Devising, implementing and testing new strategies to help optimise productivity
5. Analysing data to discover areas that need improvements and upgrades
6. Assessing compliance and adherence to safety and quality standards and reporting to higher management about their findings and proposals
7. Performing risk assessments
8. Working in conjunction with maintenance, RAQ, R&D and Commercial to support new product launches
9. Developing and implementing metrics to monitor and improve performance of processes
10. Monitoring production and in-service failures and ensuring product improvements are identified and implemented
11. Assisting in production operations to drive improvement in manufacturing efficiencies by utilising continuous improvement techniques
12. Maintaining operational efficiency and delivering operational cost savings
13. Liaising and project managing equipment suppliers and contractors in line with project budget
14. Leading the design, development, installation and validation of equipment and process for new product platforms
15. Representing Operations throughout the Design Control Process to assess and manage the risks and impact of new processes
16. Investigating and troubleshooting issues/problems
17. Production process development with full documentation support
18. Identifying and implementing new technologies, specification of requirements, Capex justification, planning and implementation
19. Process development and improvement projects
20. Developing a Continuous Improvement culture to ensure opportunities for continuous improvement are identified, prioritised, and executed
21. Reporting process trend analysis
22. Ensuring compliance to relevant medical device standards by ensuring that all Operations' Support/activities are performed in accordance with issued procedures
23. Managing CAPA and Change Control Processes, and customer complaints as per company procedures
24. Managing relevant SOPs and training
25. Conducting all relevant calibration of equipment

The Person:

1. Significant experience working within a Med Device (ISO 13485/GMP) or similar setting; will also consider candidates from a chemical background
2. Experience in process validation
3. Experience in process scale up and design transfer and project management
4. Experience in lean principles and written validations (IQ, OQ, PQ, Kaizen, FMEA, etc.)

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us.