-          Bachelor’s Degree in Engineering or Life Sciences.

-          Minimum of eight (8) years experience in the Validation/Qualification field in the Pharmaceutical, Medical Devices and/or Biotechnology Industries.

-          Solid Knowledge of  US and European pharmaceutical regulatory requirements.

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

-          Knowledge in 21 CFR Part 11 Gap Analysis and Audits, Electronic Records/Electronic Signature Assessments.

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

-          Problem solving skills, data collection, establish facts and contribute with valid conclusions.

-          Windows and Microsoft Office Proficiency, specially on MS Project.

-          Excellent supervision and management skills.

-          Willing to travel.

-          Master Degree Engineering or Life Sciences.

-          At least four (4) years of experience in related management functions, including project leader and/or personnel supervision.

-         Knowledge in any combination of the following systems and areas: PLCs, SCADA, Oracle, DCS, Millennium, SAP, LIMS systems, Laboratory Instrumentation, Document Management, and Gant Charts.   

-          Excellent mentoring and training skills.

-          Customer service oriented.

-          Trustworthy of confidential information.