|Job Ref:||204685605||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||Farnham||Address:||Post Code:||CM23||Salary:||£30000 - £40000/annum £neg. DOE + Benefits||Post Date:||19/10/2016 09:45|
We are a global healthcare / Biotechnology company specialising in the on-going development and commercialisation of products targeting cancer, critical care and other disorders. We have recently launched two highly innovative injectable products onto the market that are ground-breaking in their ability to treat cancer and cure other disorders. |
Due to continued growth we have an exciting opportunity for a Process Engineer to join our highly motivated team.
The Process Engineer will be working within manufacturing as part of the Manufacturing Technical Support function; provide technical expertise in their specialist field to deliver improvement projects and new product introductions, to increase the efficiency, effectiveness and success of Manufacturing and Supply Operations.
* Acting as subject matter expert to support delivery of medium to long term projects; to ensure availability of capacity and capability to meet commercial demand.
* Use technical expertise and influence to identify opportunities for process improvement projects for medical device and drug device combination products. Complete implementation through generation of data/technical justification, implementation and qualification.
* Provide expert technical/process engineering knowledge and investigation expertise for significant quality events in all areas of the manufacturing process. Lead identification of root cause and implementation of effective CAPAs; ensuring delivery is completed in a compliant matter.
* Implementation of change controls for process or equipment changes within Manufacturing.
* Lead and manage the process of technical transfers (including process development, scale up and new product introduction) from development to manufacturing and between sites/companies. Ensure that actions are tracked for compliance and delivery in line with agreed plans and provide regular updates/feedback to key stakeholders to ensure visibility of project progress is maintained.
* Participate in validation activities for commercial manufacturing to ensure that processes are maintained in a validated and compliant state.
* Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished in accordance with company values.
* Accountable to - MTS Manager
* Production Team, Quality Team, Validation engineers, EHS, Innovation Scientists and Engineers
Education and Experience
* Educated to degree level in Mechanical/Chemical/Process Engineering, or with significant medical device and/or pharmaceutical industry experience supported by alternative qualifications.
* Experience of Manufacturing or Product Development in the Pharmaceutical and/or Medical Device industry (some other highly regulated and quality driven industries may be considered).
* Preferably some knowledge of cGMP, ISO13485, 21CFR 820 and other relevant regulatory requirements.
* Project management experience/qualification (e.g. Prince2) would be advantageous.
* Demonstrated experience in delivering new equipment/processes into manufacturing, through sourcing, development, qualification to commercialisation.
* Demonstrated experience in existing process and equipment optimisation.
Skills and Attributes
* A dynamic and ambitious professional with proven delivery record.
* Strong team player able to demonstrate ability to lead and facilitate informal and formal teams in the development and delivery of quality solutions.
* Able to work across a matrixed organisational environment.
* Must be able to work under pressure and co-ordinate multiple activities concurrently.
* Hands on approach, problem solving mind set, good attention to detail, organised and methodical.
* Demonstrated ability to extract critical information to enable effective and appropriate decision making.
Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003