Manager, Validation Engineering

STICA STEMCELL Technologies Canada Inc.; Burnaby; On-site; CAD 117,000 - 175,000; Full time

Job summary

STEMCELL Technologies in Canada seeks a Manager, Validation Engineering to lead a team of quality validation engineers, shape QA validation strategies, and ensure regulatory compliance across our facilities. You will direct CQV, maintain QMS, monitor KPIs, and provide cross‑functional guidance to align validation practices with ISO 13485, ISO 9001 and FDA 21 CFR requirements.

This onsite leadership role offers a competitive salary, comprehensive benefits, and opportunities to advance quality and

Qualifications

• Bachelor’s degree in Sciences or Engineering (required).
• 8+ years in quality assurance in regulated environments.
• ISO 13485, ISO 9001 and FDA 21 CFR knowledge and experience.

Responsibilities

• Lead, direct, and review the work of validation engineers and set performance standards.
• Maintain Quality Management Systems (QMS) and CQV controls.
• Drive continuous improvement in QA processes by monitoring KPIs and trends.
• Provide technical guidance and allocate resources across multi-disciplinary teams.
• Collaborate cross-functionally to integrate quality and compliance into operations.

Skills

Leadership

QA Validation

RegulatoryCompliance

Cross-functionalCollaboration

Mentoring

Education

Bachelor's degree in Sciences or Engineering

Job description

Job Description Summary Are you a driven validation leader ready to shape quality standards and drive engineering excellence across complex operations? Join STEMCELL Technologies as the Manager, Validation Engineering, where you will lead a dynamic team, oversee robust Quality Assurance Validation strategies, and ensure seamless regulatory compliance at Canada’s largest biotechnology company! In this key leadership role, you will provide critical cross-functional guidance, align validation practices with industry standards, and mentor engineering professionals. You will collaborate closely with cross-departmental teams to champion innovative validation frameworks and uphold the highest quality and safety benchmarks across our facilities. If you’re a strategic thinker and proactive leader who excels in high-stakes compliance and thrives in a collaborative, fast-paced environment, we want to hear from you!

Job Description Duties and Responsibilities

• Leads, directs and reviews the work of quality validation engineers, establishes annual goals and performance standards, identifies training needs, and recommends adjustments to training materials
• Oversees and maintains Quality Management Systems (QMS), operational standards, and procedural controls necessary for the Commissioning, Qualification and Validation (CQV)
• Directs continuous improvement within quality assurance (QA) processes by monitoring and evaluating metrics and key performance indicators (KPIs) to analyze effectiveness, recognize trends, and implement operational enhancements
• Manages technical guidance and resource allocation across project teams engaged in multidisciplinary product development, lifecycle management, and design control
• Collaborates cross-functionally to integrate quality knowledge and compliance protocols into business operations and effectively resolves complex quality issues

Knowledge and Qualifications

• Bachelor’s degree in Sciences or Engineering with a minimum of 8 years of progressive experience in quality assurance in a regulated industry
• 1 to 3 years of direct experience leading, supervising, or mentoring teams
• Specialized and extensive knowledge of Quality System regulatory requirements (ISO 13485, ISO 9001, and FDA 21 CFR regulations)
• Demonstrated practical experience implementing, managing, and auditing QMS, with experience in Computer System Validation is an asset
• Proven ability to balance regulatory compliance with business and operational requirements #Nonbench #LI-Onsite #LI-ML1

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: $116,700.00 - $175,100.00. 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.

We all begin our lives curious about the world around us, the way it works and our place in it. At STEMCELL Technologies, we never lose that curiosity. It inspires and motivates us to discover and innovate. It drives us to develop technologies, create products, and offer services that will help scientists around the world do research that progresses scientific knowledge and supports breakthroughs. In the field of biotechnology, there is no better company in which to find inspiration, fulfill your potential and define your success with like-minded people. We specialize in the development of specialty cell culture media and cell isolation systems. Our products are used to drive the fields of stem cell, immunology, cancer, regenerative medicine and cellular therapy research forward. We are Scientists Helping Scientists.