Location: Ireland Cork City
Closing Date: 25 Feb 17
Type: Full Time
Salary (£): On Application
Plans, designs, develops, installs, coordinates, validates, implements and supports Data Acquisition and Control System Software projects for the production, finishing and inspection of IOLs and other Ophthalmic medical devices. 1. Responsible for planning, development, debug, installation, test, validation and support of Data Acquisition and/or Control System Software projects. 2. ...
Plans, designs, develops, installs, coordinates, validates, implements and supports Data Acquisition and Control System Software projects for the production, finishing and inspection of IOLs and other Ophthalmic medical devices.
1. Responsible for planning, development, debug, installation, test, validation and support of Data Acquisition and/or Control System Software projects.
2. Responsible for introducing and validating new equipment and/or complex new process automation projects from design through completion and in compliance with regulatory requirements.
3. Responsible for development and management of GAMP documentation e.g. URS, FDS, FAT, SAT, IOPQ etc.
4. Responsible for supporting and improving existing processes through process performance monitoring, analysis, process control, and the application of engineering principles.
5. Responsible for project management & planning and for liaising with other departments/plants affected by these projects. Also for reporting project status to management and highlighting areas of concern early.
6. Responsible for ensuring all projects are completed to agreed timelines and within budget. Also that all work adheres to H&S and environmental requirements.
7. Responsible for planning and managing projects to ensure effective utilization of resources and for liasing with R&D and/or other Alcon facilities to develop and introduce new products and processes.
8. Responsible for initiating and driving cost improvement and LEAN Manufacturing initiatives.
9. Ensure continual Quality System compliance by adherence to established and evolving Alcon and Novartis QS requirements
10. Ensure that the appropriate root cause analysis tools are used when leading NCE investigations if applicable
Minimum requirements Knowledge and practical experience of process, equipment, automation engineering projects and GAMP validation requirements.
Strong background in Allen Bradley Control Logix PLCs, iFix SCADA, MS SQL Server.
Experience in C#, VB.NET and/or OSI PI, InfinityQS software.
Knowledge of Big Data Analytics and data curation techniques.
Additional knowledge of laser printer systems, vision systems, robotics, and BCR systems.
Accustomed to working in a validated environment with strong discipline with regard to change control.
Strong analytical and problem-solving skills.
Knowledge of statistical process control and data analysis by statistical methods.
Ability to organise, plan and execute multiple tasks to tight schedules.
Highly motivated self-starter with excellent communication skills.
Well developed project management skills
Minimum:. Bachelor's Degree in Engineering, Computer Science or related fields, from an accredited College or University
Preferred: Post-graduate Degree in Electronic / Electrical / Mechatronic / Control / Software engineering
Minimum: 3-5 years experience in high volume manufacturing environment working with automated control systems in a GAMP environment.
Preferred: 5-10 years experience working with automated control systems in Regulated Industry.
Novartis Pharmaceuticals UK Limited
Frimley Business Park
|Tel:||+44 (0)1276 692255|
|Fax:||+44 (0)1276 692508|
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