Quality Engineer, Validation

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

Benefits offered by this job

Competitive salary

Excellent benefits

Career development opportunities

Job summary

STEMCELL Technologies Canada Inc. is seeking a Quality Engineer with risk-based validation experience in cGMP environments to support processes, analytical methods and equipment lifecycle verification across Manufacturing, Quality Control, Process Development and Instrumentation.

The role involves generating master plans, schedules, risk assessments, protocols and summary reports, and participating in commissioning, qualification and validation activities.

Qualifications

• Bachelor’s Degree in Biomedical Engineering or equivalent with 2–6 years in validation.
• Experience with utilities, facilities and equipment qualification (Manufacturing, Quality Control Lab, Controlled Temperature Chambers mapping).
• Excellent technical report writing with ability to analyze technical documents.
• Familiar with Continued Monitoring and Improvement concepts.
• Strong project management and time management skills; professional certifications such as ISPE, Project Management or ASQ/Six Sigma are a plus.

Responsibilities

• Develop metrics to report process effectiveness and progress against performance objectives.
• Participate in Process Performance Qualification (PPQ) conformance lots and CAPA investigations as needed.
• Prepare, review and coordinate validation, commissioning and qualification documentation.
• Ensure procedures and policies for quality assurance meet applicable medical device and/or biopharmaceutical regulations.
• Educate, train, advise and coach staff to adhere to quality standards.

Skills

Technical report writing

Project management

Time management

Quality systems

Education

Bachelor’s Degree in Biomedical Engineering

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. 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

#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: $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. 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.