Niall Orourke
Csv Lead at Amgen
Based in Dublin, Ireland
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Seniority
Manager
Department
Science
Location
Dublin
Industry
Biotechnology Research
Company size
39K
Contact information
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n•••••••@amgen.com
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Background
About Niall Orourke
An ambitious and highly adaptable author and CSV/CQV Engineer with experience working in Biologics, Active Pharmaceutical Ingredient (API) and Drug Product (Tablets) facilities. Familiar working in manufacturing sites, lab environments and facility start-up projects using systems such as Emerson Delta V DCS, IFix SCADA, Wonderware/Aveva SCADA, Siemens PLCs, Allen Bradley PLCs and OSI PI. Proficient in the use of the V-Model approach to writing validation documentation including URS, Validation Plan, Data Integrity Assessments, 21 CFR Part 11, IOQ, Reports, Trace matrix and change controls using Trackwise. Willing to relocate anywhere and open to remote roles too. For a deep dive into 21 CFR Part 11 you can check out my book “Practical Guide to 21 CFR Part 11” available to purchase on Amazon.
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