Canada-Project Engineer I
1 week ago
Project Engineer I (Engineering)
Location:Toronto, ON M2R 3T4
Duration:3+ months
Summary of Purpose:The Systems Reliability Specialist is a detail oriented, and results driven individual with a strong understanding of manufacturing systems, cGMPs, root cause analysis and possesses exceptional technical writing skills. The incumbent is responsible for Technically leading Deviation Investigations, continuous improvement initiatives, Reliability programs and maintaining technical governance & compliance to ETS departments & appropriate stakeholders.
Key Accountabilities:- Responsible for all critical, major, and minor deviations & MIs (80%):
Lead, develop/scope and execute an investigation. Strategize in collaboration with Manufacturing, Quality Operations, and SMEs – (MTech, ETS trades, QC, QOVS, QOSA, etc.), as required. Perform Root Cause Analysis by conducting Shop Floor Walkthrough (GEMBA), select appropriate analytical tools to collect and analyze data to determine true root cause. Leverage analytical engineering approach, the CMMS (SAP-PM), other historical or process data, as required. Work with Reliability professional to utilize appropriate Reliability Centered Maintenance (RCM) tools (Root Cause Analysis, Reliability modeling, FMEA's, Failure reporting, Statistical Process control monitoring, etc.), to investigate & implement appropriate Preventative actions for deviations. Prepare timely manufacturing/maintenance investigations (MIs) to support other functional areas as requested. And ensure reports are technically sound, clear, concise, and comprehensive.
Work with appropriate Engineering team to identify and develop process improvements to remediate risks, within specific platform or across the site. In collaboration with Reliability and other APU stakeholders, evaluate appropriate CAPAs scope & action, to ensure true root cause is addressed.- Responsible for Technical Governance & Compliance (20%):
Represent SP Toronto in applicable audits (TSSA & HSE). Manage all actions required to maintain compliance to all regulatory requirements, for systems active & in service. Evaluate Engineering/Vendor Turnover packages for system/equipment service life support and engage appropriately to sign-off as approver or re-submit to stakeholders for correction/completion. Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable. Present and defend investigations and provide support to appropriate ETS department during Regulatory inspections and other audits.
Participate in special project improvements for ETS systems to meet GMP requirements and address inspection observations. Participate in cross functional Engineering Technical Services team and/or deviation review board (DRB) meetings to support timely closures of Maintenance/Manufacturing Investigations and review of CAPAs for planning and execution. Education and Experience:Minimum university bachelor's degree in Instrumentation, Electrical, Mechanical or Chemical Engineering. Minimum two (2) years of previous relevant experience in manufacturing, maintenance, engineering environments; including one (1) or more working with maintenance personnel (both internal and contracted) in pharmaceutical or other related industry. High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment. Experience in regulatory inspections. Good investigation & problem-solving skills. Must possess excellent communication and organization skills. Excellent technical writing skills. Six-sigma or other root cause training and experience. Knowledge and experience with multiple software programs such as SAP, Trackwise & Microsoft Office Suite.
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