Requires a Master of Science degree in Chemical or Biological Engineering or related field, plus three 3 years of experience working in validation or quality engineering.br br Alternatively, will accept a Bachelors degree in Chemical or Biological Engineering or related field, plus five 5 years of experience working in validation or quality engineering.br br Experience must include one 1 year of managing direct reports.br br Specific skills Position also requires education or experience inbr br 1 Technical writing skills specific to the pharmaceutical industry.br br 2 Performing temperature mapping and using Kaye Validator Systems, including programming, precalibration, calibration verification, and infield execution.br br 3 Resolving deviations, including generating problem statements and descriptions, performing investigations, identifying root cause, assessing impact and justification, executing corrective and preventive actions, and closing out deviations per quality assurance standards.br br 4 Drafting and executing validation protocols IOPQ, lifecycle documents URS, FS, DS, and summary reports for manufacturing equipment, supply chain equipment, and analytical lab instruments.br br 5 Leading departments including engineering, manufacturing, process development, quality control, and quality assurance to support feasibility studies, engineering runs, commissioning, lifecycle document generation, protocol generations, qualification activities, and project management.br br 6Understanding and executing equipment, process, performance, and cleaning validation.br br 7 Testing of alarms, sequence of operations, and knowledgeable in testing requirements for specific types of equipment relevant for the industry.br br 8 Evaluating and implementing cGMP compliance requirements for consulting services company.br br 9 Business management and development.br br Any level of experience, knowledge, or coursework in the specific skills is acceptable.
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