Senior Equipment Engineer

Pay: $100.67/Hour Duration: 6+ Months Duties The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems. This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment. Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover. Might also own change control and participate in deviation/risk assessment activities. Manage medium in size and complexity equipment related projects. Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area. Technical Expertise Experience and knowledge with process systems and equipment within the following areas: Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Filling and Packaging equipment. Uses expert knowledge about the processes, automation and process-specific technology to participate in troubleshooting as the Engineering technical lead. Technical Analysis: including process system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability. Project Management Lead/participate in CAPEX/OPEX/CI projects. Own risk assessment for new systems and changes to existing systems. Write/review project execution plans. Lead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs...). Technical approvers of protocols and periodic monitoring. Lead/manage project team including overseeing & providing guidance on contractors' activities. Provides estimates of resource requirements. Qualifications Minimum of 4 years' working experience in a GMP manufacturing environment. Minimum 5 years and hands on experience with process system/equipment. Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification. Expert on troubleshooting technical issues. Owner of change control, deviation and CAPA. Capable to lead projects (CAPEX or CI). Oversee contractor(s) and provide guidance/approval on activities at site. Bachelor’s in Engineering, 5-10 years of related field experience or Master’s in Engineering, +5 years’ of related field experience or P.E. License. #J-18808-Ljbffr The Fountain Group