The Fountain Group
The Engineer, Facility is responsible to maintain the site utility system and can be the owner of those small utility equipment. This includes but not limited to WFI, CSG, Plant steam, HVAC, clean compressed gases,chiller, bldg generator and warehouse equipment. He/she will troubleshoot site utilities equipment/process issues, may support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study, equipment/process design, plan, implementation, startup, commissioning, qualification to quality release. He/she might also own change control and participate in deviation/risk assessment activities. 1) Technical Experience Responsible for the economic and reliable availability and flexibility of their system. Knowledge about the processes, automation and equipment-specific technology to participate in troubleshooting activities. Technical Analysis: including mechanical 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. 2) Project Management Participate (or lead small) CAPEX/OPEX/CI projects includes but not limited to: -Provide risk assessment for new systems and changes to existing systems. -Write simple project execution plans. -Execute startup/commissioning activities (e.g. write commissioning report, review/approve TOPs, create/update/review/approve SOPs). -Technical reviews of protocols and periodic monitoring -Lead or participate in project team including the supervision of contractors. -Provides estimates of resource requirements. 3) Optimization & Compliance Responsible for technical optimization of the field of care. Ensures that the facility equipment, machinery, documentation and technical support meets the compliance, quality and EHS standards. Contributes to, supports, or leads BPE/MPE activities to ensure a continuous optimization process. Own/execute small CAPA, deviation, change control, and risk assessment (quality, business and/or safety). 4) Global Engineering Supports implementation and improvement of best practice of technical standards, procedures. Acts as a member of Global Engineering Biopharmaceuticals and of Global Engineering Boehringer Ingelheim. Participates in peer to peer reviews. Skills: – Basic knowledge in GMP manufacturing site – Knowledge of utility equipment/system – Safety awareness in manufacturing environment – Equipment hands on experience Minimum of 2 years working experience in a GMP manufacturing environment – Hands on experience with utilities system/equipment (e.g. WFI, Plant steam, CSG, HVAC, Clean Compressed Gases,Chiller, Building Generator) – Knowledge of commercial/clinical manufacturing and warehouse operations. – Knowledge of risk assessment, root cause investigation, project startup/commissioning/qualification. – Experience with troubleshooting technical issues. – Understand compliance requirement on change control,deviation and CAPA. – Prior experience overseeing contractor activities.