Commissioning & Qualification Specialist

Experience in the pharmaceutical or medical devices industries. The candidate must have solid GMP and regulatory experience with expertise in Validations. Duties and Responsibilities 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. Requirements Experience in process validation IQ/OQ/PQ; protocols generation, execution, and reports. Generation and approval of process documentation (e.g. SOPs, etc.). Self-starter, dynamic personPosition QualificationsFully Bilingual (English/Spanish both oral and written) Knowledge of applicable US non-US applicable regulations Knowledge and proficiency in the application and principles of Validation Minimum of 2-5 years of relevant experience in Validations for packaging equipment preferably in medical device or pharmaceutical industry Bachelor Degree in Engineering or Sciences