Engineer, Facility

Responsibilities:

• Excellent employment opportunity for an Engineer, Facility in the Fremont, CA area.
• 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, building generator and warehouse equipment.
• 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.
• 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 Company.
• Participates in peer-to-peer reviews.

Experience:

• Bachelor's Degree in Engineering + 5 years of related field experience or Master Degree in Engineering + 3 year of related field experience
• 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.
• Required Skills: PLANT ENGINEERING, AC/REFRIGERATION, PRODUCTION FACILITY, GMP, ENGINEER
• Additional Skills: CAPA, CHANGE CONTROL, REFRIGERATION EQUIPMENT, FEASIBILITY, HVAC, OPERATIONS, OPEX, PROCESS DESIGN, PROJECT ENGINEER, RISK ASSESSMENT, WAREHOUSE OPERATIONS, CORRECTIVE AND PREVENTIVE ACTION