A leading injection moulding manufacturer for the life sciences/medical device sector is looking to recruit an experienced Process Engineer to join their highly experienced and established team on a temporary basis.
Experience in plastics AND/OR extrusion in a regulated environment e.g. medical device/pharma/life sciences
ISO13485 Quality Management Systems (Highly Advantageous)
Must have demonstrable experience of running process development & validation projects
Lead development of tooling & processes for Extrusion and Injection Moulding machinery.
Provide first-line support to Production for process and equipment issues.
Responsible for creating User Requirement Specifications and Functional Design Specifications for CAPEX, Business Purchases and other requirements including tools and fixtures.
Sourcing, procurement, commissioning, installation and qualification of equipment (IQOQ), tools & fixtures which may include FAT, SAT and DQ.
Responsible for generating scientific protocols, reports and required quality system documentation.
Conduct process development and validation in accordance with the requirements of the QMS, customer requirements including full documentation of all trials & validations.
Responsible for creating & maintaining documents such as Work Instructions, PFMEA, Risk Assessments, Safe Systems of Work, Training, etc.
Provide expertise to New Product Development (NPD) and support for New Product Introduction (NPI) and new technologies, sample builds & building jigs.
Develop & validate inspection and testing techniques and equipment where required for process development and validation.
Responsible for training departments on processes and equipment use.
Please note, if your application is suitable, one of our consultants will call you within 5 working days. If you have not heard from us within this time, your application has unfortunately been unsuccessful, however we will keep your CV on file to consider you for future opportunities.
ASC Connections is a leading recruitment business specialising within areas of Technical, Business and IT services. We operate as an Employment Business or an Employment Agency for all temporary and permanent roles respectively.