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CSV Engineer

I have an excellent contract opportunity for a CSV Engineer to join a cutting edge company that are devoted to the pharmaceutical market. If you are looking for a new contract and interested in been apart of the Technical Services Team this could be the contract for you!

Contract: 6 - 9 month contract

Location: Ireland, Dublin North

Hourly Rate: DOE

The company engages in research, development, manufacturing, global marketing and distribution of branded clinically proven consumer healthcare products

The CSV Engineer will have an important role to play as part of the Technical Services team, with key responsibility in the following areas:

  • Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) projects.
  • Support and co-ordinate the qualification and validation processes Support activities include, but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
  • Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures.
  • This individual will provide compliance leadership, direction and execution in Computer System Validation for new projects.

Required Skills:

  • A minimum of a Bachelor's degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech)
  • Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.

If you are interested in this role or would like to know more please send me your CV for immediate review or if you would like more information please feel free to give me a call.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales