Quality Engineer, Validation

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…