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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