Location
Fremont, CA | United States
Job description
Job Title : Project Engineer II
Location : Fremont, CA
Hours/Schedule : Mon- Fri 8am-5pm
Compensation : $95.00- $105.00
Type: contract
Overview
Join the worlds leading and largest pharmaceutical company in their ground breaking work. looking for experienced Project Engineers with experience of GMP and commercial manufacturing. Also, having exper ience with utilities system/equipment (e.g., WFI, Plant steam, CSG, HVAC, Clean Compressed Gases, Chiller, Building Generator)
Check the details below and apply at the earliest!
Responsibilities Duties:
- 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.
- 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.
- May own change control and participate in deviation/risk assessment activities.
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.
Project Management
Participate (or lead small) CAPEX/OPEX/CI projects including 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.
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.
- Owns/executes small CAPA, deviation, change control, and risk assessment (quality, business and/or safety).
Requirements - Basic knowledge in GMP manufacturing site
- Knowledge of utility equipment/system
- Safety awareness in manufacturing environment
- Hands on equipment 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.
- Understanding of compliance requirements on change control, deviation and CAPA.
- Prior experience overseeing contractor activities.
- Education:
- Bachelor’s degree in engineering + 5 years of related field experience or, Master’s degree in engineering + 3 years of related field experience
- CAPA
Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. #L1-SH1
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