Location: Canada
Date published: 04-Apr-2024
Job ID: 126099
Description and Requirements
Work Location: onsite
Position Type: Contract - 3 Months (high potential for extension)
Location: Toronto, ON
Expected Salary: $48.34 - $51.36
Our multinational pharmaceutical client seeks a Project Engineer (Systems Reliability Engineer ).
The Project Engineer/Systems Reliability Specialist is a detail-oriented and results-driven individual with a strong understanding of manufacturing systems, cGMPs, root cause analysis and exceptional technical writing skills. The incumbent is responsible for Technically leading Deviation Investigations, continuous improvement initiatives, Reliability programs and maintaining technical governance & compliance with ETS departments & appropriate stakeholders.
Responsibilities:
Responsible for all critical, significant, and minor deviations & MIs (80%):
- Lead, develop/scope and execute an investigation. As required, strategize in collaboration with Manufacturing, Quality Operations, and SMEs (MTech, ETS trades, QC, QOVS, QOSA, etc.).
- Perform Root Cause Analysis by conducting a Shop Floor Walkthrough (GEMBA) and selecting appropriate analytical tools to collect and analyze data to determine the true root cause. Leverage analytical engineering approach, the CMMS (SAP-PM), and other historical or process data, as required.
- Work with a Reliability professional to utilize appropriate Reliability-Centered Maintenance (RCM) tools (Root Cause Analysis, Reliability modelling, FMEAs, Failure reporting, Statistical Process control monitoring, etc.) to investigate and 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 the appropriate Engineering team to identify and develop process improvements to remediate risks within a specific platform or across the site.
- In collaboration with Reliability and other APU stakeholders, evaluate the appropriate scope and action of CAPAs to ensure the 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 notable project improvements for ETS systems to meet GMP requirements and address inspection observations.
- Participate in cross-functional Engineering Technical Services team and deviation review board (DRB) meetings to support timely Maintenance/Manufacturing Investigations closures and review of CAPAs for planning and execution.
- Support updating/implementing of GMP documents or actions arising from CAPAs.
HSE Requirement and Statement:
- Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.
Context of the Job/Major Challenges:
- Collaborate with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) to close deviation investigations according to targeted timelines.
Qualifications:
- Minimum university bachelor’s degree in Instrumentation, Electrical, Mechanical or Chemical Engineering
- Minimum two (2) years of previous relevant experience in manufacturing, maintenance, and 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
The indicated pay range for this position is a good-faith estimate based on the qualifications necessary for the position, including experience, training, and other considerations permitted by law. Additionally, it is emphasized that the pay band mentioned herein is the one established by the client company. Factors that may be used when making an offer may include a candidate’s skills, experience and geographic location, the expected quality and quantity of work. Most candidates will start at the bottom half of the pay range, with the upper end reserved for candidates with extensive experience and skills and who live in geographic markets commanding a higher starting pay. An employee’s pay history will not be a contributing factor where prohibited by local law.
This information is subject to change and serves as a general guideline for compensation discussions. Actual offers may vary based on specific circumstances and company policies.
All interested applicants who meet the qualifications listed above are invited to submit a resume by clicking "Apply Now".