Associate Process Engineer (12 month contract)

Aspect Biosystems•Vancouver, BC

49d•CA$64,000 - CA$72,000

About The Position

We're looking for an enthusiastic Associate Process Engineer to join our dynamic and dedicated Process Development team. Reporting to the Head of Process Development, you will support the development of an aseptic manufacturing workflow for our bioprinted tissue therapeutics. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases.

Requirements

M.S. or BSc. in Chemical Engineering, Bioengineering, Biomedical Engineering, or a related life science field with 1-2+ years of relevant industry experience, in cell therapy, bioprocess development, or biologics manufacturing.
Hands-on background in the development, characterization, and optimization of biomanufacturing processes is required, preferably within cell therapy.
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Familiarity with regulatory requirements for cell therapy products (e.g., providing technical content for CTA/IND filings).
Analytical, problem-solving, and data-driven decision-making skills.
Excellent written and verbal communication skills, including the ability to present complex data and mentor junior team members.

Nice To Haves

Experience with bioreactor systems and scaling strategies is desirable.

Responsibilities

Assisting in the design, execution, and characterization of fluidic systems, bioreactor scaling strategies, and automated cell processing workflows (wash, concentrate, harvest) to support process robustness.
Collaborating with Process Development, Bioengineering, Engineering, and Manufacturing team members to support technical integration of the cell therapy process into the final device platform, focusing on closed-system design and single-use technologies.
Participating in process risk assessments (e.g., FMEA, PHA) for both the cell manufacturing process and its interaction with the medical device component.
Utilizing mathematical models and Design of Experiments (DOE) methodologies under senior guidance to assist in defining critical process parameters (CPPs) and critical quality attributes (CQAs).
Supporting technology transfer to Manufacturing, including assisting with process qualification and early phase clinical manufacturing as needed.
Contributing to technical troubleshooting and assisting with out-of-specification investigation and root cause analysis during manufacturing deviations or process improvements.
Supporting the execution of validation strategies for sterilization, biocompatibility, and extractables/leachables (E&L), and helping compile technical data for regulatory filings (CTA/IND).
Identifying process improvement opportunities in current cell therapy manufacturing to help optimize yield, purity, and scalability.
Continuously building your technical expertise while contributing to a culture of rigor and data-driven decision-making.