Description
Validation Engineer - 6 months - Blackpool
Global FMCG company is looking for a Validation Engineer who will provide leadership to site manufacturing processes by maintaining and developing the Quality System. This includes the procedures and records required for the development, validation and production of CMW products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 9000, ISO13485, FDA QSRs and the Medical Devices Directive.
Experience:
- Demonstrable high level knowledge of product and process validation including Part 11
- Sound knowledge of cGMP and regulatory standards. Must be experienced with working within a regulated environment; a working knowledge of ISO9001, ISO13485 and/or FDA Quality System Regulations would be an advantage.
Desirable
- Ideal candidate will be a Black belt or have experience in the use of SPC techniques, Gage R&R, First Article Inspection etc.
- Ideal candidate will have a polymer processing or chemical engineering background with a proven ability to interpret and create specifications and procedures.
- Knowledge of the medical device (or closely-related, healthcare, etc) industry