Project Engineer III
Spectraforce Technologies Inc
Position Title: Project Engineer III Work Location: Fremont, CA 94555 Assignment Duration: 6 Months Work Arrangement: Onsite; 1st Shift: Mon-Fri, 8AM-5PM Position Summary:
- 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
- Minimum of 4 years' working experience in a GMP manufacturing environment
- Excellent oral and written communication skills
- Minimum 5 years and hands on experience with process system/equipment
- Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.
- Expert on troubleshooting technical issues
- Owner of change control, deviation and CAPA
- Capable to lead projects (CAPEX or CI)
- Oversee contractor(s) and provide guidance/approval on activities at site
- Bachelor's in Engineering, 5-10 years of related field experience or, Master's in Engineering, +5 years' of related field experience or P.E. License
- Regulatory requirement per GMP, OSHA and FDA
- Physical demands/surroundings - work primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile.
- Some domestic and international travel may be required.
- Visual Demands - must be able to read and see clearly with or without correction lenses.
- Attendance/schedule - attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager.
- Capable to balance conflicting priorities and agile to manage changing priorities
- Ability to establish highly functional relationships with diverse personalities
- Internal cross functional groups - Mfg, SCM, Quality, CMO, Finance, IT
- External contingency worker, contractors, possible customers, auditor
Vacancy posted 3 days ago
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