Canada-Project Engineer I
2 weeks ago
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 the true root cause.
- 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.
- Work with 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 appropriate CAPAs scope & action, 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 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.
- 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 ensure deviation investigations are closed according to targeted timelines.
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 the pharmaceutical or other related industry.
High level of knowledge of cGMPs in pharmaceutical/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.
TB_EN
#J-18808-Ljbffr-
Senior Manager, Data Engineering
4 days ago
Old Toronto, Canada Project Limited Full timeProject X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow.Our team members are trusted advisors to our clients and...
-
Canada-Project Engineer I
4 weeks ago
Toronto, ON, Canada TalentBurst, Inc. Full timeJob Title: 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...
-
Project Engineer
1 month ago
Old Toronto, Canada AtkinsRéalis Full timeProject Engineer - RoadsAre you looking for a company that works on major engineering projects all over the world? Do you want to make a difference by improving the daily lives of communities worldwide? Are you seeking to join an inclusive and diverse team that you can truly count on? You’ve come to the right place!Come join us in reshaping the future with...
-
Project Manager
1 month ago
Toronto, Canada CBCRadio-Canada Full timeJob Family Business Support Primary Location Toronto Position Language Requirement English Only Language Skill Level (Reading) - Language Skill Level (Writing) - Language Skill Level (Speaking) Status of Employment Contract Work schedule(s) Full-time **Work at CBC/Radio-Canada** **Behind the scenes, but ahead of the curve: help us develop the...
-
Civil Engineer I
3 days ago
Old Toronto, Canada City Of Vancouver Full timeRequisition ID:40918 Organization Located on the traditional, ancestral and unceded lands of the xʷməθkʷəy̓əm (Musqueam), Sḵwx̱wú7mesh (Squamish), and səlilwətaɬ (Tsleil-Waututh) Peoples, Vancouver has a commitment to becoming a City of Reconciliation. Vancouver consistently ranks as one of the world’s most liveable cities and is working...
-
Civil Engineer I
1 day ago
Old Toronto, Canada City Of Vancouver Full timeRequisition ID:40918 Organization Located on the traditional, ancestral and unceded lands of the xʷməθkʷəy̓əm (Musqueam), Sḵwx̱wú7mesh (Squamish), and səlilwətaɬ (Tsleil-Waututh) Peoples, Vancouver has a commitment to becoming a City of Reconciliation. Vancouver consistently ranks as one of the world’s most liveable cities and is working...
-
Civil Engineer I
1 day ago
Old Toronto, Canada City Of Vancouver Full timeRequisition ID:40918 Organization Located on the traditional, ancestral and unceded lands of the xʷməθkʷəy̓əm (Musqueam), Sḵwx̱wú7mesh (Squamish), and səlilwətaɬ (Tsleil-Waututh) Peoples, Vancouver has a commitment to becoming a City of Reconciliation. Vancouver consistently ranks as one of the world’s most liveable cities and is working...
-
Project Engineer
1 day ago
Old Toronto, Canada Pinchin Full timeProject Engineer, Mechanical Engineering Toronto/Mississauga, Ontario Today is the day to boost your career! Pinchin is seeking a Project Engineer to join our Mechanical Engineering team in our Mississauga, Ontario Office. Our services include more than just engineering design — we help clients understand the financial, regulatory, and operational aspects...
-
Project Engineer
1 day ago
Old Toronto, Canada Pinchin Full timeProject Engineer, Mechanical Engineering Toronto/Mississauga, Ontario Today is the day to boost your career! Pinchin is seeking a Project Engineer to join our Mechanical Engineering team in our Mississauga, Ontario Office. Our services include more than just engineering design — we help clients understand the financial, regulatory, and operational aspects...
-
Project Engineer
3 days ago
Old Toronto, Canada Pinchin Full timeProject Engineer, Mechanical Engineering Toronto/Mississauga, Ontario Today is the day to boost your career! Pinchin is seeking a Project Engineer to join our Mechanical Engineering team in our Mississauga, Ontario Office. Our services include more than just engineering design — we help clients understand the financial, regulatory, and operational aspects...
-
Director, Data Engineering
5 days ago
Old Toronto, Canada Project X Full timeAbout Project X Project X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow. Our team members are trusted advisors to...
-
Director, Data Engineering
4 days ago
Old Toronto, Canada Project X Full timeAbout Project X Project X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow. Our team members are trusted advisors to...
-
Director, Data Engineering
4 days ago
Old Toronto, Canada Project X Full timeAbout Project X Project X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow. Our team members are trusted advisors to...
-
Director, Data Engineering
1 day ago
Old Toronto, Canada Project X Full timeAbout Project X Project X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow. Our team members are trusted advisors...
-
Director, Data Engineering
1 day ago
Old Toronto, Canada Project X Full timeAbout Project X Project X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow. Our team members are trusted advisors...
-
Director, Data Engineering
1 day ago
Old Toronto, Canada Project X Full timeAbout Project X Project X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow. Our team members are trusted advisors...
-
Implementation Lead
1 week ago
Toronto, Canada i-Sight Full timei-Sight helps companies protect their employees, culture, and business through world-class software for uncovering, investigating, and preventing fraud, ethics, harassment, discrimination, and security incidents. We’re proud to count a roster of Fortune 500 companies among our customers, which have relied on i-Sight for managing millions of cases over the...
-
Director, Data Engineering
4 days ago
Old Toronto, Canada Project Limited Full timeAbout Project XProject X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow.Our team members are trusted advisors to...
-
Director, Data Engineering
4 days ago
Old Toronto, Canada Project Limited Full timeAbout Project XProject X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow.Our team members are trusted advisors to...
-
Director, Data Engineering
4 days ago
Old Toronto, Canada Project Limited Full timeAbout Project XProject X Ltd. drives success by focusing on building teams of incredibly talented and client-focused people, who love to problem solve and work on tough data problems. We reward hard work and forward-thinking with recognition and a supportive culture that celebrates success and wants to see you grow.Our team members are trusted advisors to...
