Sr. Equipment Engineer Indianapolis - RayzeBio - IN R1605108 Posted 18 hours ago

## Sr. Equipment Engineer Indianapolis - Rayze Bio - INFind out how well you match with this jobAt Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology.

Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

Learn more about Rayze Bio:
** Job Description
** Senior Engineer, Equipment Engineering is an integral part of bringing Rayze Bio’s innovative drug products to patients in need. In this role, you will report directly to the Associate Director, Equipment Engineering and be primarily responsible for equipment engineering projects supporting clinical and commercial manufacturing objectives at the Indianapolis site(s). You will design, develop, improve, and support validation and life cycle management of process equipment with novel Radiopharmaceutical technologies including but not limited to custom Hot Cells, formulation, and filling lines.

Additional responsibilities will include working with engineering firms and specialty equipment manufacturers to achieve our clinical and commercial manufacturing objectives.
** Job Responsibilities
*** Accountable for continuous operation and maintenance of process equipment for Radiopharmaceutical Clinical and Commercial manufacturing.
* Lead engineering expansion projects specific to innovative isotope and drug product radiopharmaceutical manufacturing.
* Lead development and maintenance of departmental procedures and processes related to equipment engineering activities.
* Support GMP manufacturing operations by leading and/or contributing to deviation investigations, CAPA development and execution, and change control activities, with on-call responsibility during evenings, weekends, and other non-standard business hours.
* Collaborate with Production, Quality, Digital IT, Validation and Facility Engineering counterparts to support clinical and commercial manufacturing, development and implementation of novel radiopharmaceutical technologies.
* Lead projects related to external vendors, partners and service providers as required for the design and implementation of novel radiopharmaceutical isotope and drug product equipment technologies.
* Comply with site EHS and Radiation Safety programs.
* Review, author and/or revise technical documents (SOPs, URS’s, forms, reports, etc.) as needed.
* Ability to travel as required to support job role.
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* Education and Experience:

*** Minimum 5+ years’ engineering experience on equipment is required.
* Experience in cGMP Biopharmaceutical or Radiopharmaceutical or medical device environment equipment engineering design, development and validation is preferred.
* BS in Engineering degree required / MS in Engineering degree preferred.
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* Skills:

*** GMP manufacturing equipment engineering experiences in Bio Pharma or Medical Device.
* Experience in GMP, validation, regulatory standards, and industry best practices.
* Experience managing engineering projects.
* Working knowledge of Robotics.
* Experience in clinical or commercial manufacturing of drug products or medical devices.
* Commitment to continuous improvement and operational excellence.
* Excellent professional ethics, integrity, and ability to maintain confidential information.
* Organized and detail oriented.
* Strong time…