Quality Engineer, Validation

STEMCELL Technologies, Inc.; Burnaby; On-site; CAD 84,000 - 114,000; Full time

Job summary

STEMCELL Technologies, Inc. is seeking a Quality Engineer experienced in risk-based validation within cGMP environments to support processes, analytical methods, and equipment lifecycle verification.

You will generate and support master plans, schedules, risk assessments, protocols, and summary reports, collaborating across Manufacturing, Quality Control, Process Development, and Instrumentation to execute the full project lifecycle.

Qualifications

• Bachelor’s degree in Biomedical Engineering or equivalent with 2–6 years in a validation role and familiarity with risk management (ISO 14971 and cGMP is an asset).
• Experience in utilities, facilities, and equipment qualification and software assurance.
• Excellent technical report writing and ability to analyse technical documents.
• Familiar with Continued Monitoring and Improvement concepts.
• Strong project management and time management skills; professional certifications (ISPE, PMI, ASQ/Six Sigma) are assets.

Responsibilities

• Develop metrics reporting on process effectiveness, improvement opportunities, and performance objectives.
• Participate in PPQ conformance lots and CAPA investigations as needed.
• Prepare, review, and coordinate validation, commissioning, and qualification documentation.
• Ensure procedures and policies for QA activities comply with medical device and biopharma regulations.
• Educate and coach employees to adhere to quality standards in assigned areas.

Skills

Quality Engineer

Risk-based validation

cGMP experience

Documentation skills

Project coordination

Education

Bachelor’s Degree in Biomedical Engineering or equivalent

Tools

ISPE

Validation software

Job description

Job Description Summary

Are you a Quality Engineer experienced in risk-based validation within cGMP environments? Join our team to support processes, analytical methods, and equipment lifecycle verification.

Are you a Quality Engineer experienced in risk-based validation within cGMP environments? Join our team to support processes, analytical methods, and equipment lifecycle verification. In this role, you will be responsible for generating and supporting higher level project documentation, such as master plans, schedules, risk assessments, protocols, and summary reports. This is a highly collaborative position, and you will work on the full range of project phase execution, including commissioning, qualification, validation, and project hand-over activities, within a variety of departments (e.g. Manufacturing, Quality Control, Process Development, and Instrumentation). This is your chance to work alongside motivated and intelligent individuals who are passionate about the work they do to support life science research.

Job Description

Duties and Responsibilities

• Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive continuous improvement
• Participate in the Process Performance Qualification (PPQ) conformance lot manufacturing that includes increased testing to demonstrate acceptability of the developed formulation and process; perform non-conformance and CAPA investigations as needed
• Prepare, review and/or coordinate the execution of validation, commissioning and qualification documentation
• Ensure appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device and/or biopharmaceutical regulations and products
• Educate, train, advise and coach other employees to ensure adherence to all applicable quality standards for assigned areas

Knowledge And Qualifications

• Bachelor’s Degree in Biomedical Engineering or equivalent, in combination with suitable experience (2-6 years) in a validation job and familiarity with risk management (ISO 14971 and cGMP are an asset)
• Experience in utilities, facilities, and equipment qualification (Manufacturing, Quality Control Lab, Controlled Temperature Chambers mapping and monitoring), as well as software assurance
• Excellent technical report writing and strong ability to understand and analyze technical documents
• Familiar with Continued Monitoring and Improvement concepts
• Strong project management and time management skills, with professional certifications such as ISPE Membership, Project Management, ASQ/Six Sigma Certification or equivalence is an asset

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:

$84,100.00 - $113,700.00

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.