The Validation Engineer will be responsible for managing and supporting projects through validation stages through to final approval and completion. With specific responsibility for the generation and approval of compliance packages and validation procedures. They shall also provide support to the operational team in progressing manufacturing improvement projects, driving engineering change as required.
To create robust validation documents such as Validation Master Plans, URS, DQ, FAT, SAT, IQ, OQ, & PQ’s & misc Protocols, for our products and processes.
To ensure the timely execution and approval of validation procedures and to manage any supporting activities required such as validation events, change control, documentation review / revision.
Manage validations from execution to completion ensuring all task are undertaken and completed to cGMP and OM Standard Operating Procedures.
Deliver validation projects to agreed project timing plans and customer requirements.
Monitor progress of projects to ensure timescales are maintained and status communicated to all relevant parties as appropriate.
Liaison, steering and motivation of associates in order to achieve project requirements and approved documentation.
To ensure appropriate handover packages are compiled, generated and transferred into manufacturing to ensure smooth handover and compliance in production
To make recommendations for improvements in Standard Operating Procedures , Work Instructions, Forms and Templates.
To identify and implement the training requirements to support any project activities
Support other site based engineering teams.
To ensure Health and Safety Policies and Environmental Policies are being adhered to at all times
Ensuring full compliance with all regulatory guidelines and company Standard Operations Procedures (SOP’s) at all times.
Conduct themselves at all times in a professional and courteous manner, and maintain a good appearance acceptable to our customers and management
The achievement of agreed personal objectives.
Whilst the above responsibilities constitute the primary functions of the role, the Validation Engineer may be required to carry out other reasonable tasks as dictated by the needs of the business.
Knowledge and Expertise
Highly computer literate
Excellent written English
Report and SOP writing skills
Experience of quality management systems within the medical device industry
Advanced knowledge of Design of Experiments & statistical analysis
Hours for this position are Monday - Friday 40 hours per week