Process Engineer Gmp Engineering Jobs in Ontario

Job Description Step Into a Technical Leadership Role Driving Biotech Innovation Process Engineer III - Tech Transfer Lead (Drug Substance Biotech) Imagine being the person who bridges scientific innovation and commercial manufacturing, ensuring that complex biologic processes are successfully transferred into GMP production environments. Every project you lead contributes to bringing life-changing therapies from development into reliable manufacturing, helping ensure patients receive the treatments they depend on. This opportunity sits within a highly regulated biotechnology environment where technical expertise, cross-functional collaboration, and project leadership are essential to successful technology transfer and process implementation.

What you'll achieve (and why it matters): Bring your technical expertise into a cutting-edge biologics manufacturing environment where robust process transfer and operational readiness are critical to product success: Lead end-to-end technology transfer activities for biologics drug substance manufacturing processes, including upstream and downstream operations Develop and execute transfer strategies, project plans, risk assessments, and readiness activities to support successful process implementation Partner with process development teams to transfer process knowledge, critical process parameters, and control strategies into manufacturing operations Coordinate the creation, review, and approval of technical transfer documentation, protocols, reports, and process summaries Lead cross-functional project teams, facilitating alignment across Manufacturing, Quality, Analytical, Supply Chain, Regulatory, and Technical Operations Support process scale-up, characterization, validation, and comparability activities throughout the transfer lifecycle Ensure manufacturing sites have the equipment, materials, analytical methods, and systems required for successful execution Identify technical and operational risks and drive mitigation plans to resolution Support investigations, change controls, deviations, and CAPA activities associated with technology transfer programs Provide technical oversight during engineering runs, validation campaigns, and process verification activities Drive continuous improvement initiatives using Lean Six Sigma and change management methodologies to improve process robustness and operational performance Your edge (desired, not required): Degree in Chemical Engineering, Biotechnology, Biochemistry, Biology, or a related scientific discipline 5+ years of experience in biotechnology manufacturing, process engineering, MSAT, process development, or technology transfer Strong understanding of biologics manufacturing processes, including upstream and downstream operations Experience working within GMP-regulated pharmaceutical or biotechnology environments Proven ability to lead cross-functional technical projects and manage multiple stakeholders Strong analytical, problem-solving, and communication skills Experience supporting process validation, scale-up, or commercial manufacturing activities advantageous Exposure to external manufacturing partners, CMOs, or CDMOs would be beneficial Lean Six Sigma or project management experience highly regarded Why this role matters: This is an opportunity to play a key role in transferring innovative biologic manufacturing processes into commercial production. You will work at the intersection of science, engineering, and operations while helping to ensure manufacturing excellence, regulatory compliance, and successful product delivery within a global biotechnology network. The next step for you: If this opportunity is of interest, please send your CV to danielle.johnson@nextgeneration.ie or reach out to discuss further

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