Project Engineer III

Position Title

Project Engineer III

Fremont, CA 94555

6 Months

Onsite; 1st Shift: Mon-Fri, 8AM-5PM

• The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems.
• This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment.

• The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems.
• This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment.
• Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.
• Might also own change control and participate in deviation/risk assessment activities.
• Manage medium in size and complexity equipment related projects.
• Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.

• Experience and knowledge with process systems and equipment within the following areas:
  Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Filling and Packaging equipment
• Uses expert knowledge about the processes, automation and process-specific technology to participate in troubleshooting as the Engineering technical lead.
• Technical Analysis: including process 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.

• Lead/participate in CAPEX/OPEX/CI projects
• Own risk assessment for new systems and changes to existing systems
• Write/review project execution plans
• Lead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs…)
• Technical approvers of protocols and periodic monitoring
• Lead/manage project team including overseeing & providing guidance on contractors' activities
• Provides estimates of resource requirements

• Own technical optimization of the field of care.
• Ensures that the facility equipment, machinery, documentation and technical support meet the compliance, quality and EHS standards.

• Leads/motivates activities to ensure a continuous optimization process.
• Leads/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety)
• Leads implementation and improvement of best practice of technical standards, procedures.
• Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering The Organization.
• Participates in peer-to-peer reviews as needed.

• Knowledge of GMP compliance
• Technical expertise on process equipment/system
• Recognize safety requirements in manufacturing environment
• Equipment hands on experience
• Project leadership experience