Validation Scientist Puerto Rico Kelly Science, Engineering, Technology & Telecom, Clasificados Empleos Puerto Rico

DescripciónDescription Plan, develop, and implement documentation, procedures, and training necessary for the engineering team, production and quality personnel. Generation and execution of change controls, validation plans, validation protocols FAT/SAT/IQ/OQ/PQ/CSV s, and completion reports. Provide statistical analysis of the date to support the reports. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Review and approve validations and completion reports for new and existing products, processes and equipment. Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs. Work with new and existing equipment, processes, utilities, facilities and cleaning validations.

Requisitos Requirements � Fully bilingual (English and Spanish). � Availability to work extended hours in a day and weekends as required. Education and/or experience: � BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical. � Hands-on experience with ISO11607 remediation projects, compliance projects, process validation and/or packaging validation projects required. � Experience with managing documents within electronic PLM system. � Experience with working with cross functional team. � Minimum of 5 � 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.

Requiere Mucha Experiencia Requires Expert

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