Sr Validation Specialist

Descripción del Empleo:
Our company is looking for professionals in the computer validation for Puerto Rico. Our client requires direct experience working with computer systems for the manufacturing industry and strong knowledge in Data Integrity. The CSV specialist must have strong knowledge in GAMP 5 and Part 11 compliance.
Requisitos:
BS in Engineering or Science with 5 years plus of experience in the Pharmaceutical industry (it's important: please send your resumes if you understand that you fulfill all the minimum requirements for the position). Experience in the development of Part 11 Assessments. Required experience in the development of CSV documentation such as URS, FRS, SDS, TM, VP and protocols.

Experience with Manufacturing software and hardware/infrastructure. Experience with automated system such as SCADAs, PLC, CIP/SIP systems, servers, virtual servers and others. Must have understanding of enterprise systems and validation in a GMP environment. Technical writing skills required. Good Communication skills (English/Spanish). Under professional services contract basis.