Job Description

Summary

Are you an engineer with a passion for quality and experience executing risk-based validation programs in a regulated environment? Join our team as a Quality Engineer, Validation and support the implementation, maintenance, and continued verification of a risk-based lifecycle approach to processes, analytical methods, and equipment in a cGMP environment. You will also 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 in 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.

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

Qualifications and Requirements

• Bachelor\xe2\x80\x99s 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

#United #LI-Hybrid STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. 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, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as \xe2\x80\x9cScientists Helping Scientists\xe2\x80\x9d \xe2\x80\x93 standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. 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\xe2\x80\x99s 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. NOTE: STEMCELL\xe2\x80\x99s vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process. To apply, please select the \xe2\x80\x9cApply\xe2\x80\x9d button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.