Manufacturing Engineer
3 weeks ago
Resolute Workforce Solutions (Staff augmentation subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. Our expertise is in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Project. We are looking for a highly motivated and energetic professional to join our team as a Manufacturing Engineer - Pharma in the GTA, ON. This is an on-site position.
Responsibilities:- 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.).
- 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.
- Work with Reliability professionals 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 maintenance investigations (MIs).
- Responsible for Technical Governance & Compliance (20%)
- Manage all actions required to maintain compliance to all regulatory requirements, for systems active & in service.
- 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.
Bachelor’s degree in Engineering (Instrumentation, Electrical, Mechanical or Chemical Engineering). 2+ years of relevant experience in manufacturing, maintenance, engineering environments.
Experience working with maintenance personnel (both internal and contracted) in pharmaceutical or other related industry.
Expertise in manufacturing / maintenance investigations (MIs).
High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment.
Experience in regulatory inspections.
Skilled in SAP, TrackWise & Microsoft Office Suite.
Six-sigma or other root cause training and experience.
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