Development Engineer II

Development Engineer IIIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Client: Direct ClientLocation: Lexington, MAJob Title: Development Engineer IIDuration: 1 Year + (Possible Extension)Qualifications:As a member of the Manufacturing Science & Technology group in Process Development department, this individual will join a group of process scientist and engineers to support downstream processes of commercial productions and late stage clinical process development and productions. The scope of work will include designing studies under instruction, executing experiments and data analysis to support GMP investigations and manufacturing change controls and to reduce reoccurring deviations. The focus of the work will be downstream unit operations such as column chromatography, harvest clarification, TFF and normal flow filtration. This individual will interact with other PD groups and other departments including manufacturing, PTS, QC, QA and Engineering etc.Job Functions• Design studies under management instruction, execute experiments and perform data analysis, and to continuously improve the process and to reduce reoccurring deviations• Under supervision, support root cause analysis during GMP investigations, and provide technical assessments for deviations and Change Controls• Write study proposals, research and development reports, and various technical memos• Evaluate new technologies under instructions to improve the commercial production process• Provide technical and scientific training to manufacturing supervisors and techniciansQualificationsEducation and Experience Requirements• BS degree in Chemical Engineering, Biochemistry/Protein Chemistry or related disciplines• 3 years of relevant experience in a biotechnology/pharmaceutical environment is required.• Experience with column chromatography and TFF is required.• Knowledge of the quality systems and other regulatory requirements necessary to manufacture biologics in a cGMP environment is preferred.