CSV Engineer

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Quanta Consultancy Services Ltd
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Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side 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 manufacturing 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.

Essential Duties and Responsibilities for this CSV Engineer role include, but are not limited to, the following:

- Generation, execution, review & approval of IOQ protocols and associated validation documents related to project / change controls.
- CSV assessments e.g. Part 11. 
- Participate in the review of current and future CSV procedures and policies.
- Investigate and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Coordinate with other departments or outside contractors/vendors to complete validation tasks.
- Participate in regulatory audits and communicate company computer validation policies.
- Manage projects and prepare status reports using Microsoft project and other communication tools. 

Desirable Experience:

- Experience in a GMP environment essential with Biologics experience being highly desirable. 

If you think this role could be for you, please apply today!

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

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