Specialist, Mechanical Planning

Found in: Jooble CA O C2 - 1 week ago

Toronto ON, Canada Brunel Full time

Systems Reliability Specialist (3-month contract) Toronto, ON

The Systems Reliability Specialist will be responsible for understanding the company’s manufacturing systems, cGMPs, root cause analysis and possesses exceptional technical writing skills. The successful candidate will also be responsible for technically leading Deviation Investigations, continuous improvement initiatives, Reliability programs and maintaining technical governance & compliance to ETS departments & appropriate stakeholders. This is a 3-month contract position, with the possibility of extension.

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.
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.
Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.
Collaborate with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) to ensure deviation investigations are closed according to targeted timelines.

Minimum university bachelor’s degree in Instrumentation, Electrical, Mechanical or Chemical Engineering
including one (1) or more working with maintenance personnel (both internal and contracted) in pharmaceutical or other related industry.
Experience in regulatory inspections
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

Finding the next step in your career can be a fulltime job in itself. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

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