Process Engineer
Job Description Summary
The Process and Analytical Development team is looking for a highly motivated Process Engineer to join our cell culture media team supporting expansion of STEMCELL Technologies’ cGMP facility manufacturing.As a Process Engineer, you will be joining a highly experienced and collaborative Process Development team focused on delivering robust, cost efficient, and competitive products and manufacturing processes. You will be responsible for leading the engineering design, qualification, and process validation effort to develop and commercialize fully compliant cGMP media products. This is a fantastic opportunity to apply your critical thinking skills to contribute to STEMCELL’s goal of supporting cutting edge research in the life sciences field.
Job Description
Duties and Responsibilities
Collaborate with process development and R&D scientists and engineers to develop and implement scalable, validatable, robust and reliable manufacturing processes and process control strategies
Support process development and subsequent technology transfer of new products and processes by applying appropriate Quality by Design (QbD) principles.
Author or review technical documentation, including engineering protocols and reports, engineering drawings, qualification protocol and reports, batch records, and standard operating procedures, in collaboration with Manufacturing and Quality teams
Work collaboratively with quality, regulatory, analytical, manufacturing, supply chain, and project management teams and stakeholders to ensure timely delivery of project deliverables
Knowledge and Qualifications
Bachelor’s degree in a relevant engineering discipline with 3-5 years of relevant experience
Broad knowledge of cGMP process design, development, and implementation in a regulated industry (e.g. pharmaceuticals, biotechnology, medical devices)
Experience developing and executing commissioning, qualification, and validation protocols for pharmaceutical or biotech equipment and processes
Strong verbal and written communication skills with excellent organizational skills and attention to detail
Practical experience with design and implementation of sterile liquid/drug product manufacturing, aseptic processes, and single-use technologies are an asset
#United #LI-Onsite #LI-JS1
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 base salary for this job ranges from:
$71,200.00 - $96,400.00STEMCELL 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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