Process Engineer I (Process Development)

Aspect Biosystems; Vancouver; Hybrid; CAD 77,000 - 110,000; Full time

Job summary

A leading biotechnology company in Vancouver is looking for a highly motivated Process Engineer I to support the manufacturing of implantable cell therapy products. This role involves developing manufacturing workflows, collaborating with technical teams, and preparing regulatory documents. The ideal candidate has a relevant degree and 5-7 years of industry experience in biomanufacturing processes. Competitive salary range is $77,000 - $110,000 annually along with a comprehensive benefits package.

Benefits

Equity

Comprehensive benefits package

Support for continuous learning

Qualifications

• 5-7 years of industry experience in biomanufacturing processes.
• Experience in preparation of early-stage regulatory filings.
• Strong hands-on background in biomanufacturing process optimization.

Responsibilities

• Develop aseptic manufacturing workflows for bioprinted tissue products.
• Collaborate with cross-functional teams to scale manufacturing operations.
• Prepare regulatory documents for IND filings.

Skills

Process Development

Regulatory Understanding

Analytical Techniques

Good Manufacturing Practices (GMP)

Good Documentation Practices (GDP)

Education

Master’s or Bachelor’s degree in Biomedical Engineering

Tools

Bioreactor Operation

Statistical Process Control

Job description

Process Engineer I (Process Development)

We're looking for a highly motivated Process Engineer I to join our Process Development team. This role supports manufacturing of our implantable cell therapy products, evolving processes from early-stage development through IND submission and clinical manufacturing.

Responsibilities

• Develop an aseptic manufacturing workflow for our bioprinted tissue products with phase appropriate controls for clinical manufacturing.
• Collaborate with Aspect’s Technical Operations, Research and Development, and Engineering teams to translate laboratory-scale bioprinting processes to scalable manufacturing operations.
• Prepare relevant sections of regulatory documents such as pre-IND and IND filings.
• Apply process development tools such as QbD, FMEA and Material risk assessments to prioritize activities.
• Design and conduct experiments to identify critical process parameters (CPP) and critical quality attributes (CQA).
• Ensure the preparation of materials and reagents adheres to Good Documentation Practices (GDP).
• Ensure that optimization and scaling strategies align with current Good Manufacturing Practices (cGMP) regulations including 21 CFR Parts 210 and 211 and EU Annex1.
• Assist with technology transfer to different manufacturing sites.
• Provide technical support for troubleshooting and participate in out-of specification and root cause analysis during manufacturing deviations or process improvements.

Qualifications

• A Master’s or Bachelor’s degree in Biomedical Engineering, Materials Science, or a related field, and 5-7 years of industry experience.
• Early-Stage Regulatory Understanding: Experience in preparation of early-stage regulatory filings (e.g., IND), particularly as they relate to process development and CMC sections.
• Process Development & Characterization Experience: Strong hands-on background in the development, characterization, and optimization of biomanufacturing processes is required, preferably within cell therapy.
• Experience in the design and specification of single use consumables for aseptic operation is desirable.
• Experience with cryopreservation process optimization is desirable.
• Experience with bioreactor operation and optimization is desirable.
• Experience with production and packaging of implantable medical devices is desirable.
• Analytical Techniques & Proficiency: Skilled in various analytical techniques relevant to process and product characterization, including mechanical testing, microscopy, and other relevant assays. Expertise in statistical process control methodologies and Design of Experiments (DOE) for process optimization and analysis is essential.
• GMP & GDP Knowledge: Thorough knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Mission-Driven: You are passionate about enabling the development of life-changing therapies and driving high standards to support patient safety and product excellence.

The hiring range for this role is $77,000 - $110,000 annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. Base salary is one part of the overall compensation at Aspect, which also includes equity, a comprehensive benefits package, and support for continuous learning and career progression.

Who We Are

Aspect Biosystems is a Canadian biotechnology company creating bioprinted tissue therapeutics to transform how we treat disease. We are committed to creating an inclusive environment for everyone on our team and do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or other protected characteristics.