NavitsPartners
Associate Deviation Management Specialist
NavitsPartners, Lansdale, Pennsylvania, United States, 19446
Position:
Associate Deviation Management Specialist -IILocation:
West Point, PADuration:
12 months
Job Description:Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing investigationsThis individual will be responsible for providing scientific support for manufacturing areas within the Client's Manufacturing Division (MMD)This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviationsTroubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required Analysis of complex problems through critical analytical thinkingOff-shift work may be requiredQualifications:
S./M.S. degree in appropriate engineering/scientific fieldMinimum of 3-5 years post-Bachelor's degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industryPrevious experience in writing investigations for atypical events in a manufacturing environmentFamiliar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilitiesDemonstrated ability of meeting goals/timelines/organizational skillsExcellent written and verbal communication skillsDemonstrated ability to work both independently and as a part of a cross-functional teamPreferable skills-Environmental monitoring experience, Formulation and filling experience, Line manufacturing experience (project engineer, maintenance and facility engineer, Experience in Bulk/Drug substance Manufacturing).
Associate Deviation Management Specialist -IILocation:
West Point, PADuration:
12 months
Job Description:Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing investigationsThis individual will be responsible for providing scientific support for manufacturing areas within the Client's Manufacturing Division (MMD)This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviationsTroubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required Analysis of complex problems through critical analytical thinkingOff-shift work may be requiredQualifications:
S./M.S. degree in appropriate engineering/scientific fieldMinimum of 3-5 years post-Bachelor's degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industryPrevious experience in writing investigations for atypical events in a manufacturing environmentFamiliar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilitiesDemonstrated ability of meeting goals/timelines/organizational skillsExcellent written and verbal communication skillsDemonstrated ability to work both independently and as a part of a cross-functional teamPreferable skills-Environmental monitoring experience, Formulation and filling experience, Line manufacturing experience (project engineer, maintenance and facility engineer, Experience in Bulk/Drug substance Manufacturing).