An opportunity has arisen for a Process Validation Engineer to join our Clients Winsford Site Engineering Team. The role will support both R&D projects and Operations optimisation and validation work. This role will be responsible for the optimal technical performance of the manufacturing process including maintaining optimal standard processes, delivering continuous improvement within the process and delivering process outputs in line with business objectives. The role will be part of the Operations team at Winsford reporting into the Site Engineering Manager.
Optimisation of the technical performance for manufacturing processes.
Establish & maintain standard processes within the validated process window delivering outputs in line with the business objectives on safety, quality, delivery and cost.
Improve the manufacturing process via capability enhancement & process development.
Ensure equipment and processes are validated to plan and in compliance with the relevant medical device regulations
Develop best in class processes for machine and process validation
Responsible for training the engineering team and technical operators in machine and process validation procedures where they become competent in carrying out and documenting all validations assigned to them
The ideal candidate will have:
Experience in process / manufacturing engineering or process validation, specifically within converting and/or packaging processes in the medical device industry.
Excellent leadership, influencing, analytical and communication skills
Knowledge of IQ/OQ/PQ processes & relevant report writing
Decision making within framework of company, ISO and FDA standards
Experience in leading projects in the respect of quality, time, cost, communication
Ability to analyse business needs and make recommendations based on sound business knowledge and commercial acumen
Have a pragmatic approach whilst working within a team and autonomously
Strong working knowledge of Microsoft Office software Word, Excel, Powerpoint & Min-Tab. Working knowledge of AutoCAD and/or SolidWorks.
Knowledge and experience of plant and machine related health & safety / regulatory compliance requirements
Degree / HNC qualified in Mechanical, Biomedical, Industrial, or Manufacturing Engineering.
If you are interested in this role please call Karen Blondel 01606 591991