Project Engineer III

Pay Rate Range: $100 - $107.14/hr. on W2Duties: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 projectsOwn risk assessment for new systems and changes to existing systemsWrite/review project execution plansLead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve, TOPs, create/update/review/approve SOPs...)Technical approvers of protocols and periodic monitoringLead/manage project team including overseeing & providing guidance on contractors' activitiesProvides estimates of resource requirementsOptimization & Compliance:Own technical optimization of the field of care.Ensures that the facility equipment, machinery, documentation and technical support meet the compliance, quality and EHS standards.Leads/motivates activities to ensure a continuous optimization process.Leads/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety)Global Engineering:Leads implementation and improvement of best practice of technical standards, procedures.Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering Client.Participates in peer-to-peer reviews as needed.Regulatory and/or Organizational Requirements:Regulatory requirement per GMP, OSHA and FDAPhysical demands/surroundings - work primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile.Some domestic and international travel may be required.Visual Demands - must be able to read and see clearly with or without correction lenses.Attendance/schedule - attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager.Job Complexity:Capable to balance conflicting priorities and agile to manage changing prioritiesAbility to establish highly functional relationships with diverse personalitiesInternal cross functional groups - Mfg, SCM, Quality, CMO, Finance, ITExternal contingency worker, contractors, possible customers, auditorSkills:Knowledge of GMP complianceTechnical expertise on process equipment/systemRecognize safety requirements in manufacturing environmentEquipment hands on experienceProject leadership experienceMinimum of 4 years' working experience in a GMP manufacturing environmentExcellent oral and written communication skillsMinimum 5 years and hands on experience with process system/equipmentCapable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.Expert on troubleshooting technical issuesOwner of change control, deviation and CAPACapable to lead projects (CAPEX or CI)Oversee contractor(s) and provide guidance/approval on activities at siteEducation: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