Commissioning & Qualification Specialist

Performvalidation of packaging equipment for Bio-tech product.Protocol execution for validation of Cold Room.Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis.Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations SOPs, specifications and other applicable acceptance criteria.Prepares and coordinate qualification activities.Communicate with the staff and management on ways of implementing plans and recommendations. RequirementsExperience in process validation IQ/OQ/PQ; protocols generation, execution, and reports.Generation and approval of process documentation (e.g. SOPs, etc.).Self-starter, dynamic personFully Bilingual (English/Spanish both oral and written)Knowledge of applicable US non-US applicable regulationsKnowledge and proficiency in the application and principles of ValidationMinimum of 2-5 years of relevant experience in Validations for packaging equipment preferably in medical device or pharmaceutical industryBachelor Degree in Engineering or SciencesPowered by JazzHR