Qualification-Validation-Spec-Cip-Process

Descripción del Empleo:
Prepare qualification (Installation, Operational and Performance) protocols and reports for new or modified Facilities, Manufacturing and Packaging Equipment, Product Contact and Non-Product Contact Utilities, HVAC and CTUs. Prepare Cleaning and Process validation protocols according to internal and external requirements. Execute qualification, cleaning and process validation tests in accordance to approved protocols, procedures and guidelines. Analyze cleaning and process validation test data to determine whether systems or processes have met validation criteria. Write process and cleaning validation final reports that present, summarize and offer conclusions based on the validation test results. Participate in investigations related to qualification and/or validation activities to identify root cause of deviations. Other duties may be assigned.
Requisitos:
Minimum 4 years of experience in a related position in the regulated industry. Experience with the following: process equipment, packaging equipment, cleaning systems (CIP), thermal mapping, critical utilities (Nitrogen, Compressed Air, HVAC, Water Systems), cleaning and process validation, planning and execution. Experience in pharmaceutical cGMP regulated environment. Ability to work independently and effectively under pressure, handle multiple tasks and meet deadlines. Statistical knowledge preferred. Bilingual ( English and Spanish). Excellent Communication and Writing Skills. Bachelor degree in Science or Engineering Completed. Available to work different shift when needed. Qualified candidate please send your resume to **********