It Validation Jobs in Indiana (NOW HIRING)

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. From day one, expect to make an immediate impact-on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/
Job Description
Senior Engineer, Equipment Engineering is an integral part of bringing RayzeBio'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.

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.

Skills:

• GMP manufacturing equipment engineering experiences 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. Be 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 also 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.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
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.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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 include:
Paid Time Off

• 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 for employees 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 Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
RayzeBio and Bristol Myers Squibb
RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
Supporting People with Disabilities
BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.
R1605108 : Sr. Equipment Engineer