Project Engineer II - LanceSoft Inc
Fremont, CA
About the Job
Duties:
FACILITIES ENGINEER
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.
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 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.
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.
Owns/executes 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 ***.
Participates in peer-to-peer reviews.
Skills:
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.
FACILITIES ENGINEER
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.
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 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.
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.
Owns/executes 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 ***.
Participates in peer-to-peer reviews.
Skills:
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.
Source : LanceSoft Inc