Computer Systems Validation Engineer

Job type:
on-site
Start:
11/2015
Duration:
n.a
From:
Real Staffing
Place:
Republic of Ireland
Date:
11/10/2015
Country:
flag_no Ireland
project ID:
1017145

Warning
This project is archived and not active any more.
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Job Requirements
  • 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.
  • Development of life cycle documents necessary to address the validation lifecycle (Planning, Risk, Implementation, and maintenance of the validated state).
  • 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. Review/Approval of all Computer Systems/Software Validation Documentation.


Qualifications
  • Bachelor's degree in Computer Science, Computer Engineering, Computer Information Systems, plus 3 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: Windchill, TrackWise, Master Control, Agile PLM Software, Aegis, SharePoint, Oracle, SQL, Manufacturing Execution Systems, LIMS, LIS, software quality testingetc.
  • Prior experience in working with cGMPs and/or GLPs,and Quality Systems is preferred.
  • Experience working in the Pharmaceutical/Medical Device industry.


This is a fantastic opportunity to join a growing and dynamic company with competitive hourly rates. If you would like to hear more please contact me on or reply with your most recent CV.

Please also feel free to get in touch if you know of anyone suitable for this position as we offer shopping vouchers for any successful referrals - great for present buying on the run up to Christmas!