Overview
Manufacturing Engineer Jobs in Edmonton, Alberta, Canada at PE Global (UK)
The role:
PE Global is currently recruiting for a Sr QA Specialist – External Manufacturing on behalf of a leading biotech company in Dublin South. This is an initial 18-month contract role.
Responsibilities:
Manage and execute total quality management systems for the External Supply organization (Raw Materials, Devices, and Contract Manufacturing).
Execute nonconformance, CAPA, SICAR, Change Control, and oversee metrics. Act as the category owner for all quality records and procedures.
Process, investigate, and respond to deviations, ensuring compliance with regulatory agencies.
Monitor deviations, determine corrective and preventive actions, and communicate with relevant authorities to modify manufacturing or packaging processes based on analyses.
Maintain unified procedures for product defect investigations.
Provide technical expertise to optimize deviation management and prevent recurrence.
Ensure investigations are completed per quality standards and procedures.
Communicate across organizational levels, develop solutions for critical issues, and generate reports.
Serve as the primary contact between Site Plant Quality and the Supplier Quality Management team regarding raw material quality.
Education and Experience:
Doctorate with 2+ years of Quality/Manufacturing experience, OR
Master’s with 6+ years, OR
Bachelor’s with 8+ years, OR
Associate’s with 10+ years of relevant experience.
Additional requirements include:
6+ years in biotech or pharmaceutical manufacturing, process development, or quality assurance, with demonstrated compliance, problem-solving, root cause analysis, project management, and quality systems experience.
Knowledge of quality management systems and quality control related to Raw Materials in clinical and commercial operations.
Thorough understanding of EU and US cGMP regulations.
Ability to work independently, organize data, and communicate effectively.
Leadership skills for cross-functional projects and navigating ambiguity.
Ability to defend processes during regulatory inspections.
Strong relationship-building skills across functions.
Excellent oral and written communication skills, especially for investigation responses.
Understanding of Operational Excellence and Root Cause Analysis.
Proficiency in MS Word, Excel, PowerPoint, Visio, Project, and Trackwise.
Negotiation skills and ability to maintain remote relationships.
Interested candidates should submit an updated CV.
Apply via the provided link, call Kellie at , or email your CV to
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* Note:
Candidates must have the correct visa to work in Ireland; sponsorship is not provided.***
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Title: Manufacturing Engineer
Company: PE Global (UK)
Location: Edmonton, Alberta, Canada
Category: Quality Assurance – QA/QC (Quality Engineering, Quality Control / Manager)
