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AUTOMATION VALIDATION ENGINEER
Company:ENTERPRISE SYSTEM PARTNERS |
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Job Reference Number |
14336307 |
Client ID: |
RI/AVDL |
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Posted On: |
Jun 25 2010 |
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Location: |
LEINSTER, DUBLIN |
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Job Type: |
Contract/Permanent |
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Salary: |
?45,000 TO ?65,000 DOE |
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Benefits: |
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We are a rapidly growing company that needs highly motivated people to help drive it forward.
AUTOMATION VALIDATION ENGINEER
RESPONSIBILITIES :
· Contribute to/lead management of system vendors (including equipment vendors with automation systems in their scope). Scope documents, URS, FDS/DDS, Acceptance testing (FAT & SAT), Integration testing.
· Attendance at FAT and monitoring vendor progress to ensure compliance with overall schedule
· Contribute to validation in the areas of protocol development, review, execution and reporting including DQ, IQ, OQ, and PQ
· Contribute to the rollout in the areas of SOP review, training, cutover scheduling and interface with the business
SCOPE:
Functionality may include:
· Weigh & Dispense
· Work Flow Management/Order Management/EBR
· Planning & Scheduling
· Material Flow Control
· Equipment & Container Management
· CAPA Management
· Training & Qualification Management
· ERP Interface
· Automation Layer Interface
· Automated Goods Vehicles and interface to MES
REQUIREMENTS:
· Minimum of three years validation experience in a pharmaceutical or biotech facility
· A solid understanding of Automation systems such as SCADA, DCS
· Experience of generating and executing system protocols
· Knowledge of FDA and GMP guidelines
We offer contract permanent positions with excellent package for successful candidates
ABOUT US:
Enterprise System Partners (ESP) Ltd is a highly successful project engineering company, which provides systems support to the life science industry in Ireland for the planning, vendor selection, design and implementation of systems from the automation layer (DCS, SCADA) right up to the ERP layer (e.g. SAP, JD Edwards) with particular expertise in manufacturing and laboratory systems. Our unique strength is our people collectively understand the entire system landscape within the manufacturing environment. This includes expertise in Manufacturing Execution Systems (MES), (including document management systems, maintenance/calibration systems, CAPA systems, Material Tracking Systems, Electronic Batch Records and W&D) and integration of these systems throughout the entire systems landscape. We have offices in Cork and Dublin, with our team based on pharmaceutical plants around the country.
