"Experis, part of the Manpower Group manage all recruitment for Sanofi, Waterford. Sanofi is situated on a 37 acre site in Waterford. This multi phased Biopharmaceutical facility employs over 600 personnel and is one of Irelands Great Places to work."
On behalf of Sanofi we are recruiting a CSV Engineer to partner with their project teams in performing Information Systems CSV at their site. 12 Month contract.
The activities would include:
- Coordinates, performs, and assists in the development of computerized system and computerised equipment life cycle documentation and tasks to establish computerized systems that meet regulatory requirements and industry standards.
- Life cycle documentation include but not limited to: user requirement specifications, FDS / HDS, GxP assessments, Computer System lifecycle assessments and ERES traceability matrices, standard operating procedures, IQ, OQ and PQ protocols, validation master plans and summary reports.
- Development and execution of the qualification of Information Technologies (IT) Infrastructure (i.e., servers, networks and network components) following the GAMP IT Infrastructure Guide.
- Development and execution of qualification & validation of Information Systems software (GAMP category 1, 2, 4 and 5) following GAMP5 guidance.
- Provide assistance where required with the preparation/testing of validation protocols and all associated documentation for equipment/systems.
- Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
- Ensure that appropriate Site Validation system listing is established and controlled.
- Review/Approval of all Computer Systems/Software Validation Documentation and periodic reviews.
- Seeks out and recommends to management opportunities for increased quality system efficiencies and operational improvement through modifications to current systems, implementation of new systems, and more efficient use of established systems.
- A Bachelor's degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or three years relevant experience).
- Experience with the management, development and/or validation of Information Systems Technology projects is preferred.
- This experience may include but is not limited to the following: TrackWise, SharePoint, Oracle, SQL, Manufacturing Execution Systems, LIMS, LIS, software quality testing etc.
- Prior experience in working with cGMPs and/or GLPs, and Quality Systems is preferred.
- Data Integrity Experience.
- Experience working in the Pharmaceutical / Medical Device industry.
Skills & Knowledge
- Have the ability to communicate IT/Validation concepts/strategies to project teams.
- Be a self-starter and be motivated to provide a solid product quality and customer experience.
- Be adaptable to a fast pace working and team based environment
- Be able to integrate and interact well within the customer environment.
For more info on this role contact Paul on 01 6455 250 or email