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Form of workJob Description
Job Description:
Pay Range $95.67hr - $100.67hr
- The Engineer Facility is responsible to maintain the site utility system and can be the owner of those small utility equipment.
- This includes but is 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.
- 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).
- Global Engineering: Supports implementation and improvement of best practice of technical standards, procedures.
- Participates in peer-to-peer reviews.
- 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.
- Bachelor s degree in engineering + 5 years of related field experience.
- Master s degree in engineering + 3 years of related field experience.
