Salary / Rate: Negotiable depending on expertise.
Type: Fixed Term or Contract.
Purpose of Role:
The purpose of this role is to provide subject matter expertise to lead such activities. The majority of these matters lie at the interface between the primary and secondary pack and the device or manufacturing process.
The role is global and will require the incumbent to work across all phases of the projects.
Lead problem solving teams or continuous improvement activities within the R&D context.
You will compile Design Control documentation and contribute to a high quality Design History File (DHF).
· To generate troubleshooting procedures, flowcharts or tables.
- To identify and diagnose the "trouble" in the process flow of a corporation or a system caused by failure.
- To initiate processes, corrective action plans, to prevent further or future failures.
- To identify and isolate the specific cause, malfunction or causes of the symptom and report.
- To introduce or review methods, procedures and processes using a wide range of analytical or other techniques.
- To evaluate trends and complaints.
- Support Global Sterile R&D device development activities ensuring the right packs, device, processes or strategy have been selected.
- Set and review specifications for packaging components and raw materials.
- Supporting projects and processes through identification and implementation of technical solutions that involve packaging material selection and testing, interactions with packaging materials, packaging machinability, components assembly and manufacturing or packaging processes.
- Provide technical input to the Injectable Device Technology and Packaging landscape.
- Initiate, plan, organise and/or execute packaging simulation and compatibility testing.
- Provide technical support to define and continuously improve Business Development activities for injectable devices, combination products and technical processes.
- Manage relationships with primary, secondary pack and device suppliers, manufacturers, contract design houses, contract manufacturing companies, specialist test houses.
- Evaluate higher barrier value creation product or process opportunities to be added to further the sterile pipeline.
- Supporting packaging and device developments initiatives and processes from concept to commercialization.
- Working closely with R&D units, regulatory, quality assurance, operations, business teams, functional partners, packaging suppliers and manufacturers.
Knowledge, Skills and Competencies:
Graduate in Process Engineering, Device Engineering, Packaging Technology or similar/Post Graduate Education e.g. Material Science, Physics, Chemistry;
Significant track record in management of trouble shooting activities;
Proficiency in use of project management tools;
Ability to work in Cross functional teams;
In-depth knowledge (through practical experience) of GMP, EU and FDA regulatory requirements;
Understanding of packaging, device development and manufacturing processes;
Understanding of packaging or device and drug/device combination regulatory and quality requirements;
PACKAGING / R&D / RESEARCH AND DEVELOPMENT / PRODUCT DESIGN / PRODUCT DEVELOPMENT / LABELLING / MANUFACTURING / MEDICAL DEVICES / DEVICES / PHARMACEUTICAL / MEDICAL / HEALTHCARE / LIFE SCIENCES / COMBINATION PRODUCTS / INJECTABLES / SYRINGES / STERILES / CONVATEC / BESPAK / MEDTRADE / AMS / ADVANCE MEDICAL SOLUTIONS / ASTRA ZENECA / SANOFI / PFIZER / GSK / GLAXO / MEDICAL TEECHNOLOGY / TECHNOLOGY / PACKAGING / REGUALTORY AFFAIRS / SCIENTIFIC / CHESHIRE / MANCHESTER / LIVERPOOL / CHESTER / NORTH WALES / WREXHAM / STAFFORDSHIRE / LANCASTER / LANCASHIRE / UK / UNITED KINGDOM / DERBY / DERBYSHIRE / CLINICAL RESEARCH
- Medical Devices
- R&D Operations
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