Csv Engineer

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 InfrastructureCreate System Design Specification, Qualification Plan, IQ/OQ.
Protocol Development Only and Summary Report.
Project 2 – OPC Interface ServerCreate 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.
#J-18808-Ljbffr