01Overview
Design and development of drug combination products; focused on injectables by understanding design space and managing critical design parameters.Using design for manufacturing principles as well as geometric dimensioning and tolerance tools to create sound engineering drawings.Identify the best tools and approaches to effectively solve engineering problems.To develop, optimize and analyze designs by applying the appropriate mix of engineering principles, analytical, and experimental methods.Demonstrated ability to utilize statistical tools, computer analysis and engineering fundamentals to solve complex engineering problems. SolidWorks experience is requiredSupport the evaluation and assessment of new technologies, intellectual property, products, and processesSupport current products in terms of quality, manufacturing, and cost improvement.Support execution of technical and cross-functional project work.Write detailed technical reports based on design verification testing for design changes and product design activities.Conduct due diligence on devices based on business, and regulatory requirementsDevelop and implement detailed test methodsDevelop realistic and actionable design plans.Effectively collaborate with laboratory technicians and support staff.Ensure compliance with Lupin quality policies, standard operating procedures and practicesMust have knowledge of and experience with Factory Acceptance Testing, Process Validation and IQ/OQ/PQs.Must demonstrate knowledge of US regulatory and quality requirements such as 21CFR820.30 .
