Computer System Validation (CSV) Engineer
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| Job Type | Contractor |
| Area | Mayo, Ireland |
| Sector | IT/Software |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002293 |
| Job Views | 119 |
- Description
- This is the job for you, if you are a qualified in Engineering or Computer Science you want to work for a progressive company. Our client is recruiting on a contract basis to join their dynamic IT team in Westport. You will support upgrading custom and COTS ap-plications by authoring change controls, risk assessments, integration protocols, test scripts and summary reports and by updating SOPS, training material and equipment asset care activities as required. Great communication skills are essential to ensure delivery of the CSV implementation projects within agreed timescales.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
What you will bedoing:
Give guidance to the project team on up-to-date and relevant regulatory requirements.
Make sure upgrades are executed and delivered in a timely manner.
Create and promote good practices to continuously improve the quality and effectiveness of the IT processes
Complying with regulatory standards
Partner with all stakeholders to ensure consistency in quality approach, including: third parties quality management, internal control and risk management
Predictive Compliance Planning and Remediation
Produce weekly and monthly dashboards
Help updating of SOP’s
Review & approvals of documentation in line requirements
Inspection readiness of the project
What you need to apply:
Bachelor degree in Engineering, Computer Science, or related.
Experience is dependent on your level so for Juniors we are looking for 2+ years, for mid-level it’s 4+ years, and for senior level it’s 10+ years in in Pharmaceutical and/or Medical device industry.
Software development experience
In-depth understanding of relevant GAMP and relevant EU/FDA regulations around software and data systems.
All-embracing experience with GxP and GDP practices, 21 CFR Part 11 and good working knowledge of Data Integrity
Demonstrated ability to work without direct supervision within a complex project team.
Brilliant verbal and written communication skills.
Experience with delivering complex projects, ideally related to legacy manufacturing modernisation / manufacturing system upgrades
CSV experience in at least one of the following areas: Laboratories, Aseptic Processing or packaging equipment.
