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We're looking for an experienced Compliance Engineer to join a company in Royston. You will work within the R&D team ensuring that products are designed and built to meet conformance requirements needed for the chemistry and pharmaceutical sectors.
You will be involved during the whole product development lifecycle, ensuring specifications are properly defined, risk assessments are carried out, the development process is followed and products conform to all the legal requirements. You will keep up to date with current regulations and be a key resource of knowledge for compliance.
* Applying, researching and learning about regulatory standards that govern company products designed and supplied to the chemistry and pharmaceutical sectors., typically CE, NRTL, GMP, GAMP and ATEX
* Maintaining a reference database of standards
* Working with external compliance consultants
* Working with CE and NRTL notified bodies e.g. UL, TUV, CSA etc and preparing conformance documentation
* A good understanding of the requirements on manufacturers for CE Marking and the practical application of the latest EU Low Voltage, EMC, Machinery, RoHS, Reach and WEEE Directives is required.
* Experience in compliance and conformance within an industrial environment
* An understanding of current industrial electrical safety control methods and standards
* Experience of CE marking and certifying products
* Ability to understand engineering drawings and specifications
* Confident in discussions and presentations
* Capable of individual research to keep abreast of current regulatory requirements
Additionally, the following would be useful:
* Experience of Product Data Management systems (PDM, PLM)
* Background working in the Chemical or Pharmaceutical industries
* Knowledge of pressure vessels and related directives
* A working knowledge of GMP principles and processes
* Experience of ATEX within industrial process environments
* Familiarity with GAMP for automation and control systems
* Ability to speak Japanese
[ Royston, Hertfordshire, Salary £neg. | vacancy reference : 32704 ]