-          Bachelor’s Degree in Engineering or Life Sciences

-          The position requires at least four (4) years of experience related to Validation/Qualification duties in the Pharmaceutical, Medical Devices and/or Biotechnology Industries

-          Expertise in Validation/Qualification Documentation such as: Master Plan, Design Reviews, Protocols, Reports, Investigations, Deviations, CSV Life Cycle Documents, and SOPs

-          Expertise in Validation/Qualification Execution

-          Basic knowledge is 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

-          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

-          Excellent supervision and management skills

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

-          Initiative, Motivation and Organization

-          Good interpersonal skills

-          Excellent Good Documentation Practices