Associate 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

The Associate Engineer in the facilities group with an equipment engineering focus is responsible for all aspects of installation, commissioning, qualification, process improvement, and maintenance of equipment needed to support facilities and operations at the POINT Indianapolis site. The position is based in Indianapolis, Indiana, U.S. and reports directly to the Facilities Engineering Manager. The position will observe typical business hours, Monday through Friday. Some evening or weekend work may be required on an occasional basis.

Responsibilities

• Support engineering capital and change projects through specification, procurement, installation, commissioning, qualification and hand-over.
• Lead the installation, commissioning, and qualification of manufacturing, packaging and process equipment.
• Support the preparation and review of URS, DS/DQ, FMEA, IQOQ documentation and protocols for new equipment.
• Maintain a detailed and expert knowledge of current and future innovative and diverse pharmaceutical platform technologies, with a strong emphasis in high level automation and control systems as well as cutting edge mechanical processes and systems.
• Maintenance and day-to-day troubleshooting of manufacturing, packaging, and process equipment issues as required.
• Provide engineering support for building management systems, including control and monitoring systems, ensuring 21 CFR Part 11 compliance for system monitoring and reporting.
• Mentor fellow engineering, maintenance and technical stakeholders in mechanical and automation technologies and applications.
• Identify machine and process improvements to minimize downtime and drive operational excellence.
• Assist maintaining and improving POINT equipment and compliance systems as needed.
• Occasional travel for training, equipment procurement, and vendor site validation.

Requirements

Education and Experience:

• Bachelor’s degree in Engineering or Science preferred. Associates degree with additional experience or military training will be considered. Focus in automation, electronics, and robotics is preferred.
• Minimum 2 years of experience working as an equipment engineer supporting engineering, facilities, and operations of manufacturing facilities, preferably in an FDA regulated operation such as the drug product, medical device, or food and beverage manufacturing industries.
• Experience working with small-volume parenteral, sterile unit-dose filling, or radiopharmaceutical drug product is preferred.

Competencies:

• Excellent verbal and written communications skills with technical or cross-functional audiences, and proven ability to work independently with external suppliers.
• Flexible attitude to help where necessary in a startup culture.
• Demonstrated ability to excel in a collaborative team environment.
• Ability to plan, develop and execute multiple projects under tight timelines.
• Excellent organizational and interpersonal skills.
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
• Manage multiple projects, set priorities, and work in a fast-paced environment

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected