Senior Engineer
Core
Senior Engineer leading visual inspection strategies and process development for biologics drug products (large molecule, RNA, virus) to support commercialization and lifecycle management.
Role type
Senior Engineer (Process Development & Quality Assurance)
Builds
Robust visual inspection strategies, characterization protocols, and process development studies for biologics.
Domain
Biotechnology / Pharmaceutical Manufacturing / Visual Inspection
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Visual inspection technical expertise, process development, data analytics, statistical analysis, risk assessment, CAPA implementation, regulatory document authoring, root cause analysis, cross-functional collaboration, lean study design, in silico modeling, generative AI application, LLM utilization.
Preferred skills
PhD, industry experience in development and manufacturing visual inspection, Knapp studies experience, packaging and inspection equipment experience, pharma inspection background.
Technologies
Generative AI, Large Language Models (LLMs), in silico modeling, statistical analysis software.
Responsibilities
Serve as technical SME for visual inspection and troubleshoot complex issues; Participate in Drug Product Commercialization Teams for process development and lifecycle management; Own and improve business processes for defect kit preparation; Establish testing strategies and develop characterization protocols; Interface with inspection teams across manufacturing sites; Plan, design, execute, and document laboratory studies for formulation and fill/finish; Apply first principles modeling to solve technical problems; Perform data analysis using advanced statistical techniques; Provide support to manufacturing operations for troubleshooting and product impact assessments; Author and review guideline documents and regulatory sections; Conduct risk assessments and implement CAPA; Identify operational opportunities for inspection operations; Lead cross-site teams as needed; Ensure inspection operations meet FDA, EU, and international quality standards.
Seniority
Senior, hands-on IC with technical leadership
