Senior Engineer

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

POINT Biopharma is an innovative, high-performance company focused on a hard problem: extending and improving the quality of life for patients enduring cancer. Our products are targeted radioligands, a technology that holds significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment established our U.S. manufacturing center in Indianapolis and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Reporting to the Manager of Project Engineering, 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.

Objectives

• 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.

Accountabilities

• Applies engineering and scientific principles to the evaluation and solution of equipment and system