Karen Ashworth has a fascinating role as Validation Consultant at Schneider Electric™. She specialises in how to design, document, implement and test computer systems that are going to control or monitor pharmaceutical manufacturing processes.
Karen describes herself as a consultant whose role it is to focus on Schneider Electric's control and monitoring systems that are effectively used in a pharmaceutical environment. She manages projects on Schneider's behalf and enjoys working with her team as they're very committed to 'doing things properly' which is vital in her kind of environment. "You'd really want to be able to rely on the control system getting things right if you're going to be taking the medicines it produces," comments Karen.
What Karen enjoys most in her role is working with customers to define their needs, then undertaking testing and commissioning onsite to prove that those needs have been met.
Working in the nuclear industry
Karen has a degree in Engineering and was sponsored at university by British Nuclear Fuels, who she then went to work for as a graduate. "My first role involved designing a control system for a nuclear reprocessing plant. I then moved to Sellafield to become a shift leader on the Vitrification Plant which turns the highly active waste products from reprocessing into glass which is sealed into steel canisters for safe long term storage. I later returned to designing control systems at Eurotherm (now part of Schneider Electric) in Worthing and my experience working in the highly regulated nuclear industry transferred neatly over into working in pharmaceuticals.
Developing international best practice
For the last 16 years, Karen has been running her own company specialising in validating control systems for pharmaceutical applications and has continued to work closely with Eurotherm and then Schneider Electric throughout that time. "I've also been heavily involved in developing international best practice in this area working on the GAMP (Good Automated Manufacturing Practice) good practice guide for validation of process control systems and leading the team who updated the good practice guide for testing systems in this environment and, most recently, leading a team who are writing a pragmatic guide to data integrity in process control systems," explains Karen. One of Karen's career highlights has in fact been when she was invited to be a member of the UK GAMP steering committee.
One of Karen's more recently completed large projects with Schneider Electric involved foraying out from pure pharmaceuticals into hygiene products and related to a huge batch control system that manufactures the liquids used in some big name household products. Karen's work is certainly never dull, and she thrives on each new challenge.
Karen recommends Schneider Electric as a great place to work due to the great work culture, interesting projects and of course the fabulous teams of people.
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