Job Description Summary Do you enjoy solving complex problems, building relationships with collaborators, and continuously learning in a fast-paced and innovative environment? As a Senior Process Engineer, you will work alongside experienced scientists and engineers who collaborate closely on delivering robust, cost efficient, and innovative processes for the manufacture of biologics products!
In this role, you'll be involved in the engineering and process design for a new biologics manufacturing facility to support STEMCELL's next phase of growth. This will include the design, qualification, and process validation efforts to develop, scale up, and continuously improve both new and existing products. This is a fantastic opportunity to contribute towards STEMCELL's mission of Scientists Helping Scientists and supporting cutting edge research in the life sciences field!
Job Description Duties and Responsibilities- Work with internal and external parties to develop Conceptual and Basis of Design documents for new manufacturing facilities, and assist in resolving process design issues that arise during construction
- Collaborate with engineers and scientists to establish requirements for clean utilities and cleanroom environments using the requirements defined for the various manufacturing processes
- Oversee and support process equipment design, documentation, evaluation, selection, and approval of third-party equipment
- Draft and review technical documentation, including engineering reports and standard operating procedures, in collaboration with Manufacturing and Quality teams
- Work with internal stakeholders to ensure timely delivery of project deliverables
- Develop and implement scalable, validatable, robust, and reliable manufacturing processes and process control strategies related to both upstream and downstream operations
Knowledge and Qualifications- Bachelor's degree in a relevant engineering discipline with at least 5 years of experience in a related role
- Broad knowledge of bioprocess design, development, and implementation in a regulated industry (e.g. pharmaceuticals, biotechnology, medical devices) is preferred
- Experience developing and executing the commissioning, qualification, and validation protocols for pharmaceutical or biotechnology equipment and processes
- Broad knowledge of cGMP Regulations relating to the manufacture of regulated pharmaceutical products
- Competency in designing regulated and non-regulated biologics manufacturing facilities and associated equipment and utilities is required
#United #LI-Hybrid #LI-AS1
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 2300 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:
$78,640.00 - $118,000.00
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.
NOTE: STEMCELL'svaccination 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.
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Category
Management and Executive