Senior Quality Engineer, Validation

STEMCELL Technologies Inc; Burnaby; On-site; CAD 95,000 - 142,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Career development opportunities

Job summary

STEMCELL Technologies Inc is seeking a Senior Quality Engineer, Validation to lead CQV strategies for equipment, facilities and processes. You will ensure regulatory alignment and drive audit-ready documentation while supporting ongoing manufacturing operations and new product launches.

The role involves risk assessments, FMEA, validation testing for software and equipment, and process improvements to strengthen quality systems.

Qualifications

• Bachelor’s degree in Engineering with 6–10 years of relevant experience; Master’s degree with 4+ years is acceptable.
• Knowledge of mechanical, chemical, electrical and software engineering disciplines and applying them to manufacturing and product development.
• Experience with ERP and QMS in ISO 13485 or GMP environments; exposure to sterile/high-volume manufacturing is a plus.
• Familiarity with regulatory standards including ISO 13485, FDA 21 CFR Part 820, and ISPE; ability to develop risk documentation and apply risk-based validation.
• Strong organizational, prioritization, and project management skills; able to support products per specifications.

Responsibilities

• Develop comprehensive validation strategies for processes, systems and equipment in line with regulatory requirements and best practices.
• Perform risk assessments and determine critical validation requirements and documentation.
• Conduct FMEA and other risk management activities to identify and mitigate validation risks.
• Lead complex validation testing for equipment, utilities, software and processes; ensure performance within defined parameters.
• Identify opportunities to improve validation processes through data analysis and non-conformance review.

Skills

Certified Quality Engineer

Quality Systems

Education

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Software, or Biomedical)

Master’s degree in Engineering

P.Eng. designation (asset)

Tools

ERP systems

Quality Management Systems (QMS)

Job description

Job Description Summary

STEMCELL Technologies’ Quality Assurance Validation team is growing and we are looking for a Senior Quality Engineer, Validation to join our team!

As the Senior Quality Engineer, Validation, you will ensure that commissioning, qualification, and validation (CQV) strategies and documentation for equipment, facilities, and processes are accurately captured and addressed. You will support existing manufacturing operations and new product launches, serving as the primary point of contact for CQV-related topics. By identifying and recommending improvements to validation processes, you will help ensure that STEMCELL’s manufacturing equipment, processes, and systems are audit- and market-ready.

Job Description

Duties and Responsibilities

• Implement comprehensive validation strategies for processes, systems, and equipment, ensuring alignment of validation activities with regulatory requirements and industry best practices

• Conduct risk and impact assessments to determine the criticality of systems, process and equipment, identify validation requirements, and establish the required validation documentation

• Conduct risk management activities, including Failure Mode and Effects Analysis (FMEA), to identify, assess, and mitigate risks associated with process and equipment validation

• Execute and lead complex validation testing for equipment, utilities, software, and processes, ensuring functionality and performance within defined parameters and providing validation expertise through successful project completion

• Identify and assess opportunities for validation process improvements through data analysis, risk assessments and non-conformance results analysis, to position STEMCELL better from a regulatory and operational standpoint

Knowledge and Qualifications

• Bachelor’s degree in Engineering, preferably Mechanical, Chemical, Electrical, Software, or Biomedical, with 6–10 years of relevant experience, or a Master’s degree with 4+ years of relevant experience; Certified Quality Engineer preferred and P.Eng. designation considered an asset

• Knowledge of a broad range of mechanical, chemical, electrical and software engineering disciplines, with experience applying engineering principles to manufacturing and product development

• Experience with Enterprise Resource Planning and Quality Management Systems, ideally within an ISO 13485 or GMP-regulated environment; experience in sterile and high-volume manufacturing, Consumer Packaged Goods, pharmaceuticals, cannabis, cosmetics, or similar highly regulated industries is preferred. Ability to understand and assess complex designs and manufacturing requirements is required

• Working knowledge of regulatory standards and quality requirements, including ISO 13485, FDA 21 CFR Part 820, and ISPE, with experience developing risk documentation and applying risk-based validation approaches and statistical methods to establish processes that support manufacturing products in accordance with design inputs and specifications

• Strong organizational, prioritization, and project management skills, with the ability to assess complex designs and manufacturing requirements and support products in accordance with specifications

#LI-KK1 #LI-Onsite #Bench

STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 1,800 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.

As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

The annual salary for this job ranges from:

$94,600.00 - $142,000.00

STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.