Stop the press!!! Calling out all Validation Engineer and need to speak with you about an exciting opportunity to join a Global Leading Medical Device company based in Oxford.
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.
The Validation Engineers key responsibilities will be as follows..
· To create robust validation documents such as Validation Master Plans, URS, DQ, FAT, SAT, IQ, OQ, & PQ’s & 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 tasks are undertaken and completed to GMP 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 statuses are 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 be successful in this role, the Validation Engineer will have the following skills and experience.
· To be 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
· Excellent reactive attitude
· Highly organised with acute attention to detail
· Positive and pro-active
· Ability to communicate & build relationships at all levels
· Excellent time-management skill
What you will receive in return?
You will be joining a successful, privately owned industry leader who are constantly innovating and looking to improve lives, empower patients and relieve the pressure on healthcare professionals. We invest heavily in our staff and offer a competitive salary and benefits package along with the opportunity to develop within the business. Additional benefits include:
· Generous shift allowances
· Enhanced paid break allowances on shift
· 25 days annual leave (with the opportunity to earn loyalty days with length of service)
· Holiday purchase scheme (up to 10 days purchased per holiday year)
· Enhanced Family Friendly Policies
· Enhanced Sickness Pay
· Group Life Insurance
· Wellbeing initiatives and support
· Annual company bonus
· Free parking, free tea & coffee and free fruit