Quality CSV Engineer-00000RSN
Description
LifeScan is a Johnson & Johnson company. LifeScan Scotland was created in 2001 when Johnson & Johnson acquired the UK assets of Inverness Medical Ltd, a medical device company established in Inverness in 1995 to design and manufacture glucose test strips, and design electronic meters for the global diabetes market. Around 1,100 people are employed at the Inverness facility, which is regarded as a centre of excellence for those working in the field of diabetes.
With a focus on future development, LifeScan is committed to "creating a world without limits for people with diabetes." LifeScan Scotland's main product range includes the popular OneTouch® Brand of blood glucose monitoring systems, which is available globally. The company has also developed diabetes management software, control solutions and lancing devices and, in addition, produces the specialist test strips that work with many of the meters in the OneTouch Brand line.
Quality CSV Engineer
Role profile: To provide validation support for the validation activities associated with computer systems ensuring that all compliance issues and requirements of LifeScan Validation Policies and Procedures are addressed.
Main responsibilities may include:
v To coordinate projects associated with the validation of computer systems (IT, Control and End user) as directed
v To organize and lead Validation working parties associated with the computer systems, providing a timely validation coordination service to Project Managers or identified Project Leaders
v To provide support and input to CSV Team Leader to work towards a LifeScan common computer systems validation process
v To provide informationon current regulatory and company standards that must be met to achieve and maintain compliance
v To ensure that all validation activities and documents are authorised and appropriate compliance approval is gained
v Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health and safety, company operations, and/or the environment
Qualifications
Essential criteria includes:
v Degree in relevant discipline (eg. Electrical/Electronic Engineering, Information Systems or Life Science with additional IT qualification)
v Previous experience working in a regulated industry carrying out validation and/or testing activities.)
v Knowledge of bespoke computer software and/or hardware specification, testing and documentation
v Project management skills
v Self directed; ability to work with minimal supervision
v Knowledge of the specification, testing and implementation of computer applications for business within an FDA regulated industry
v Pro-active problem resolution
v Change management skills
v Lean experience
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Will government officials please identify themselves on application for the purpose of the Foreign Corrupt Practices Act. If you apply for the role, any personal data which you provide shall be processed by LifeScan Scotland, a Johnson & Johnson company, for the purpose of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-Scotland-Inverness
Organization: Lifescan Scotland Limited (form. Inverness Medical (7691)
Job Function: Engineering (Generalist)
Description
LifeScan is a Johnson & Johnson company. LifeScan Scotland was created in 2001 when Johnson & Johnson acquired the UK assets of Inverness Medical Ltd, a medical device company established in Inverness in 1995 to design and manufacture glucose test strips, and design electronic meters for the global diabetes market. Around 1,100 people are employed at the Inverness facility, which is regarded as a centre of excellence for those working in the field of diabetes.
With a focus on future development, LifeScan is committed to "creating a world without limits for people with diabetes." LifeScan Scotland's main product range includes the popular OneTouch® Brand of blood glucose monitoring systems, which is available globally. The company has also developed diabetes management software, control solutions and lancing devices and, in addition, produces the specialist test strips that work with many of the meters in the OneTouch Brand line.
Quality CSV Engineer
Role profile: To provide validation support for the validation activities associated with computer systems ensuring that all compliance issues and requirements of LifeScan Validation Policies and Procedures are addressed.
Main responsibilities may include:
v To coordinate projects associated with the validation of computer systems (IT, Control and End user) as directed
v To organize and lead Validation working parties associated with the computer systems, providing a timely validation coordination service to Project Managers or identified Project Leaders
v To provide support and input to CSV Team Leader to work towards a LifeScan common computer systems validation process
v To provide informationon current regulatory and company standards that must be met to achieve and maintain compliance
v To ensure that all validation activities and documents are authorised and appropriate compliance approval is gained
v Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health and safety, company operations, and/or the environment
Qualifications
Essential criteria includes:
v Degree in relevant discipline (eg. Electrical/Electronic Engineering, Information Systems or Life Science with additional IT qualification)
v Previous experience working in a regulated industry carrying out validation and/or testing activities.)
v Knowledge of bespoke computer software and/or hardware specification, testing and documentation
v Project management skills
v Self directed; ability to work with minimal supervision
v Knowledge of the specification, testing and implementation of computer applications for business within an FDA regulated industry
v Pro-active problem resolution
v Change management skills
v Lean experience
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Will government officials please identify themselves on application for the purpose of the Foreign Corrupt Practices Act. If you apply for the role, any personal data which you provide shall be processed by LifeScan Scotland, a Johnson & Johnson company, for the purpose of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-Scotland-Inverness
Organization: Lifescan Scotland Limited (form. Inverness Medical (7691)
Job Function: Engineering (Generalist)