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DescripciónDescription
Plans, 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. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Recommend process/quality improvements. Work with new and existing equipment, processes, utilities, facilities and cleaning validations, to include (but not limited to) Packaging Equipment (e.g. Multivac Machine), freeze-drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters, chillers, controlled temperature units, and laboratory equipment. Temporary Contract (one year) 1532 |
Requisitos Requirements
BS in Engineering (Mech., Ind., Electrical, Chem., or Biomedical or science related discipline. Lean/Six Sigma Green or Black Belt Certification is a plus. Experience in validations: manufacturing and packaging equipment, laboratory equipment, cleaning, test method, computer systems, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required. Minimum of 5-7 years of experience in medical device or pharmaceutical manufacturing, with FIVE (5) YEARS IN VALIDATION ENGINEERING POSITION. Knowledge of Packaging components and equipment is highly desirable. Knowledge of FDA, BSI, OSHA, EPA, and GMP's and ISO requirements. Ability to lead teams through complex projects and provide departmental technical leadership. Excellent communication skills and a strong track record of working cross-functionally. Fully bilingual.
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