Senior Commissioning and Qualification Engineer I
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What you'll do
- Manage commissioning and qualification activities for facilities, utilities, equipment, and support systems in accordance with approved plans, procedures, and quality requirements
- Recommend and review validation protocols, standard operating procedures (SOPs), and technical reports
- Collaborate with cross-functional teams and external vendors to organize qualification activities and support project schedules
- Evaluate qualification results, identify deviations from expected outcomes, and support implementation of corrective actions in accordance with established procedures
- Oversee compliance with company policies, regulatory guidelines, quality standards, and safety procedures
What they're looking for
- Bachelor's degree with 6-10 years of relevant experience
- Commissioning and qualification lifecycle expertise
- GMP validation, documentation and data integrity practices
- Risk assessment and deviation management
- Regulatory compliance knowledge
Nice to have
- Professional Engineering (P.Eng) designation preferred
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Job Description Summary
STEMCELL Technologies, Canada’s largest biotech company is looking for a Senior Commissioning and Qualification Engineer to join the team out of our main headquarters in Burnaby!In this role, you will lead the commissioning, qualification and validation activities for our facilities, utilities and laboratory equipment. You will provide support to ensure compliant and reliable operations are maintained. You will also contribute technical expertise and cross-functional coordination to support successful system qualification and operational readiness. This is an exciting opportunity for someone who is looking for a hands-on role within a multidisciplinary, solution-driven team.
Job Description
Duties and Responsibilities
Manage commissioning and qualification activities for facilities, utilities, equipment, and support systems in accordance with approved plans, procedures, and quality requirements
Recommend and review validation protocols, standard operating procedures (SOPs), and technical reports
Collaborate with cross-functional teams and external vendors to organize qualification activities and support project schedules
Evaluate qualification results, identify deviations from expected outcomes, and support implementation of corrective actions in accordance with established procedures
Oversee compliance with company policies, regulatory guidelines, quality standards, and safety procedures
Knowledge and Qualifications
Bachelor's degree with 6-10 years of relevant experience
Professional Engineering (P.Eng) designation preferred
Commissioning and qualification lifecycle expertise
GMP validation, documentation and data integrity practices
Risk assessment and deviation management
Regulatory compliance knowledge
#NonBench #LI-Onsite #LI-KP1
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 - $142,000.00STEMCELL 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.
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Company
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