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 the other parts of the facility too (various equipment).
The Role:
- Preparing process documentation and operating instructions
- Overseeing and assessing new and existing processes and workflows
- Meeting with production managers to assess existing processes.
- Devising, implementing and testing new strategies to help optimise productivity
- Analysing data to discover areas that need improvements and upgrades
- Assessing compliance and adherence to safety and quality standards and reporting to higher management about their findings and proposals
- Performing risk assessments.
- Work in conjunction with maintenance, RAQ, R&D and Commercial to support new products launches.
- Develop and implement metrics to monitor and improve performance of processes
- Monitor production and in-service failures and ensure product improvements are identified and implemented.
- Assist in production operations to drive improvement in manufacturing efficiencies by utilising continuous improvement techniques.
- Maintain operational efficiency and deliver operational cost savings.
- Liaise, project manage equipment suppliers and contractors in line with project budget.
- Lead the design, development, installation and validation of equipment and process for new product platforms.
- Represent Operations throughout the Design Control Process to assess and manage the risks and impact of new processes.
- Investigates and troubleshoot issues/problems.
- Production process development with full documentation support.
- Identify and implement new technologies, specification of requirements, Capex justification, planning and implementation.
- Process development and improvement projects.
- Develop a Continuous Improvement culture to ensure opportunities for continuous improvement are identified, prioritised, and executed.
- Report process trend analysis
- Ensures compliance to relevant medical device standards by ensuring that all Operations' Support/activities are performed in accordance with issued procedures. Hence, any non-compliances are highlighted to the Process Engineering Manager.
- Manages CAPA and Change Control Processes, and customer complaints as per company procedures.
- Manages relevant SOPs and training.
- Conducts all relevant calibration of equipment.
The Person:
- Significant experience working within a Med Device (ISO 13485/GMP) or similar setting. Will also consider candidates from a chemical background.
- Experience in process validation
- Experience om process scale up and design transfer and project management
- Will have experience in lean principles and written validations (IQ, OQ, PQ, Kaizen, FMEA etc)
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