Company Description
Westbourne is a trans-global organisation currently with delivery centres in Cork and Auckland. Our business strategy is to leverage our existing experience and expertise in delivering a broad range of IT services to a growing list of clients in the Life Science sector. As we continue to grow we are seeking to hire a CSV Engineer to work within the Westbourne Lab IT Project team.
Computer Systems Validation Engineer
Current Projects for execution with our client by the CSV Engineer:
Project 1 – OSIsoft PI System Enterprise Infrastructure
Create System Design Specification, Qualification Plan, IQ/OQ. Protocol Development Only and Summary Report.
Project 2 – OPC Interface Server
Create System Design Specification, URS, Risk Assessment, Part 11 Assessment, Validation Plan and IQ/OQ/PQ. Protocol Development Only and Summary Report.
Work Experience
* Experience of working in a GMP pharmaceutical manufacturing or QC operation is essential.
* Minimum 3-5 years’ experience in a CSV Engineer working with automation systems.
* Strong People Skills to work effectively with business and IT leadership, peers and reports.
* Preferred experience working with OSIsoft PI system.
Qualifications/Training
* Hold a recognised Computer System Validation (CSV) or GAMP5 qualification.
* Familiar with Annex 11/21 CFR Part 11 requirements, GAMP5 and data integrity guidelines.
Behaviours
* Evidence of self-motivation and ability to deliver to time and quality goals.
* Strong oral and written communication skills, with proven ability to communicate and build relationships cross-functionally.
* Willingness to travel within Ireland.
* "Customer first” mind-set.
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