Sr. Equipment Engineer

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio 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.

About the role

As Senior Engineer, Equipment Engineering, 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. You will also work with engineering firms and specialty equipment manufacturers to achieve our clinical and commercial manufacturing objectives.

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.
• Travel as required to support job role.

Requirements

• Minimum 5+ years’ engineering experience on equipment.
• 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.

Skills

• GMP manufacturing equipment engineering experience in BioPharma 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 management and organizational skills.
• Strong interpersonal communication skills.
• Motivated, adaptable, accountable and collaborative.
• Able to support in a manufacturing environment under pressure.
• Uses AI tools to enhance individual productivity and quality of work.

Physical Requirements

• Standard office environment coupled with GMP production and facility environment.
• Responsibilities include the ability to lift 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• Ability to sit or stand for long periods of time while performing duties.
• Must be willing to wear personal protective equipment (PPE) as required.
• Must be comfortable working with radioactive materials.
• Protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Pay

Indianapolis - RayzeBio - IN: $107,904 - $130,754. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • Paid Time Off for US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or RayzeBio employees).
  • Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.