Project Risk Engineer F/M

2 months ago

Toronto ON, Canada Raise Full time

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.

Strategize in collaboration with Manufacturing, Quality Operations, and SMEs – (MTech, ETS trades, QC, QOVS, QOSA, etc.), 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 appropriate Engineering team to identify and develop process improvements to remediate risks, within specific platform or across the site.
# Responsible for Technical Governance & Compliance (20%):
# 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.
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