-          Bachelor’s Degree or Master’s Degree in IT, Engineering or Computer Science

-          The position requires at least two (2) years of experience in Computer System Validation/Qualification in the Pharmaceutical, Medical Devices and/or Biotechnology Industries

-         Basic knowledge in CSV documentation such as Master Plans, Functional Specifications, GxP’s,  User Requirements, Traceability Matrix, SOP’s, Protocols, and Reports

-         Knowledge in 21 CFR Part 11 Gap Analysis and Audits, Electronic Records/Electronic Signature Assessments, IOP/Q development and execution, CSV basic testing such as interlocks, inputs and outputs, alarms, and security levels.

-          Must be fully bilingual (English/Spanish) and must demonstrate excellent written skills, especially in the preparation of technical reports

-          Proficiency in Windows and Microsoft Office applications

-          Ability in analyzing and generating data

-          Ability to perform the assigned work within schedule, quality, and budget

-          Initiative, Motivation and Organization

-          Good interpersonal skills

-          Knowledge in Good Documentation Practices