Senior Engineer

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

About POINT Biopharma:

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.

Position Summary:

The Senior Engineer will engage with cross functional teams to ensure manufacturing system designs, processes, and procedures are created and accurate within established timing requirements in a GMP manufacturing facility. This engineering role will become a Subject Matter Expert on processing equipment in a clean room (classified environment) for clinical and commercial operations. The Senior Engineer will be responsible for understand and approving design details, assessing risk as it relates to equipment and processes, executing on project tasks, managing aspects of project implementation, following quality procedures (i.e., Change Control), create and execute validation requirements, and support manufacturing systems.

Roles and Responsibilities of the Position:

· Provide engineering direction from project concept through qualification on new and existing manufacturing systems.

· Review specification control drawings and other applicable specifications to determine requirements and/or feasibility of the component.

· Perform all necessary scientific and/or engineering studies and calculations.

· Prepare preliminary design proposals.

· Interact with production personnel to define and solve manufacturing/design issues and implement improvements.

· Perform liaison function between Engineering and all manufacturing operations for any related issues, problems, or improvements.

· Conduct risk analysis and develop risk mitigations actions.

· Create acceptance criteria and conduct acceptance tests.

· Prepare process validation protocols, execute, and document results.

· Interact and manage vendors concerning parts or equipment they supply or propose to supply.

· Prepare RFP (request for proposal) and RFQ (request for quotation) documents.

· Participate in engineering and general design review as required.

· Prepare technical data such as qualification test procedures, acceptance test procedures, reports, component maintenance manuals, etc.

· Direct the integration of technical activities and products.

· Evaluate and approve design changes, specifications, and drawings.

· Maintain specification and operational documentation as required.

· Keep manager advised of work status, workload, problems, and progress as related to work assignments.

· Prepare project plan, schedule, budget, and interim reports.

· Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

· Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

· Maintains a clean, orderly, and safe workstation and environment at all times.

· Applies engineering and scientific principles to the evaluation and solution of equipment and system problems.

· Managing projects and creating dashboards for report outs.

· Effectively communicates moderately complex technical issues and solutions to a cross functional team.

· Collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations.

· Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Required Qualifications:

· Bachelor’s degree in an Engineering discipline or equivalent required

· 8+ years related experience required

· Proficient in MS Office applic