CSV Engineer

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Quanta Consultancy Services Ltd
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An exciting opportunity has arisen to work for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the site is workable for those wishing to commute to / from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours. 

The vacancy at present is for a CSV (computer systems validation) Engineer.

This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. 

The role will involve:

- Generation, execution, review & approval of IOQ protocols and associated validation documents and CSV assessments e.g. Part11 Assessments, etc. related to IT Infrastructure systems and related IT Applications and system components
- Prepareing/reviewing validation documentation related to projects/change controls.
- Manageing change controls and other compliance related tasks e.g. non-conformances.
- Participating in the review of current and future CSV procedures and polices
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Participating in regulatory audits and communicates company’s computer validation policies. 

Education and Experience:

- Requires BS/BA in Engineering, Chemistry, or Life Sciences with related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
- Experience in a GMP environment essential.

Does this sound like the role for you? If so, please apply today with an up to date version of your CV and a member of our team will be in touch to discuss this opportunity in further detail!

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Contact Details:
Quanta Consultancy Services Ltd
Tel: (0) 1442 860 521
Contact: Nicolle Kniebe

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