Process Development Engineer
Job Description SummarySTEMCELL plans to build a state-of-the-art cGMP facility to manufacture magnetic nanoparticles that support our EasySep™cell isolation products. If you are a Process Engineer who has process development experience, has designed process equipment and process workflows used in API/chemical processes and products complying with cGMP manufacturing requirements, and is motivated to contribute towards Scientists developing life-saving technologies for patients, join us!
The position is anchored within the Process Development team of highly experienced Scientists and Process Engineers who collaborate closely on delivering robust, cost efficient, competitive products and manufacturing processes. As a Process Development Engineer, you will be responsible for leading the engineering design, qualification, and process validation effort to develop and commercialize a fully compliant cGMP product based on our current ISO compliant EasySep™ nanoparticle product.
The ideal candidate will be someone who takes initiative, enjoys critical thinking and solving complex problems, enjoys building and nurturing collaborative relationships across departments, and takes pleasure in learning continuously.
Duties and Responsibilities
- Design and perform process development activities using appropriate Quality by Design practices to enable robust manufacturing processes and ensuring new products are manufactured predictively and efficiently.
- 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.
- Lead and support process equipment design and documentation, evaluation, selection, and approval of third-party equipment as required by applicable GMP manufacturing regulations.
- Support technology transfer of new products and processes from development stage to commercial production, including lab scale ups and plant trials.
- Draft and review engineering reports, SOPs, and all associated technical documentation in collaboration with MFG and QA.
- Develop risk management strategies using gap analysis and pFMEAs, and execute appropriate risk mitigation activities.
- Work collaboratively with quality, regulatory, analytical, manufacturing, supply chain and project management teams to ensure timely delivery of the cGMP product.
- Collaborate with QA and associated teams to ensure the implementation of highest possible quality standards throughout the manufacturing and process development.
- Lead process safety reviews through HAZOPS, FMEAs and risk assessments.
- Support day-to-day execution of experiments, analyze data, summarize findings and present technical data to technical and non-technical audiences.
Bachelor’s in Engineering with 5+ years of relevant experience or Master’s in Engineering with 4+ years relevant experience.
Broad knowledge of cGMP process design, process development, and implementation in API/biotech.
Experience in IQ/OQ/PQ/CQV of pharmaceutical or biotech equipment/processes.
Experience in drafting, reviewing and approving documentation necessary for meeting FDA regulatory requirements.
An understanding of regulatory standards and FDA requirements.
Strong organizational skills and attention to detail.
Experience with practical design & operation of TFF flow systems or aseptic processing is an asset.
Excellent collaboration, teamwork and communication skills.
This role requires vaccination against COVID-19 as per the current recommendations by local health authorities, including any COVID-19 boosters as recommended by local health authorities and where available.
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 “Scientists Helping Scientists” – 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 significant career development opportunities.
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