Vacancy Description
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 Engineering Manager (PEM) to work at their modern manufacturing facility in Coventry; responsible for the Process Engineer (PE) the PEM will be the go-to' person for validation/ process validation, quality management processes and process engineering tasks. 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:
• Manage, review, and take overall responsibility for all Process Engineering tasks.
• Challenge existing Manufacturing process to deliver Process efficiencies.
• Provide project management for Operations projects.
• Manage Quality Management processes such as CAPA and change control associated with production processes.
• Draft specifications / packaging, feasibility studies, written validations, SOP's.
• Conduct OQ/PQ Trials.
• Ensure Operations are represented throughout the Design Control Process.
• Manage responsibility for design transfer and all process validation activities.
• Provide product Process support for products post design transfer.
• Drive proactive risk management and continuous improvement practices such as FMEA, Kaizen and Lean methodologies.
• Implement process improvements to achieve/exceed company KPI targets.
• Present justifications for investment to deliver process improvements to increase Clients competitiveness.
• Optimisation of productivity, cost and processing time through the supply chain administration areas
• Monitoring the progress and effectiveness of efficiency improvements and regular visualisation
• Carrying out value analysis and value stream mapping
• Support production Operator process training.
• Implement appropriate statistical tools to maintain and improve production processes.
• Liaise and manage equipment suppliers and contractors.
The Person:
• Will ideally hold a degree in a relevant STEM based discipline (not essential)
• 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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