**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Quality Engineer will work cross-functionally to develop and implement engineering solutions that enhance compliance and reliability. This position will be responsible for providing quality oversight on the execution and update of the Validation Master Plan and site metrics. This position provides guidance on CAPA plans and use statistical tools to identify trends and promote continuous improvement. The Sr. Quality Engineer will be responsible for leading root cause analysis efforts using risk management principles. Supporting a Multi-phase to commercial facility. This position reports directly to the Associate Director, of Quality, Indianapolis. ***This is an onsite position located at Rayzebio's Indianapolis, IN site*** **Job Responsibilities:** + Provide quality support and oversight of equipment validation, computer systems validation, and change management. + Provide quality review and support for the calibration and preventive maintenance programs. + Lead continuous improvement initiatives through cross-functional support and project management techniques. + Participate with the Facilities, Engineering and MS&T teams on new installations/systems and innovation. + Leads cross-functional efforts for process improvement projects through use of statistical tools and various risk analysis tools. + Apply current industry standards and regulations to ensure procedures and policies are compliant with FDA, EU and ISPE GAMP-5 guidelines. + Support the enrollment and approval of assets in the asset management system. **Education and Experience:** + BS/MS in Science related discipline preferred with 5-6+ years of quality assurance or quality engineering experience + Experience working in a GMP aseptic manufacturing environment preferred + Experience working with FDA and EU regulations. + ASQ or ISO certification and previous auditing experience a plus **Skills and Qualifications:** + Highly motivated and organized professional with the ability to work independently + Working knowledge of 21 CFR Parts 11, 210, 211 and EU annex + Very personable with strong communication skills + Ability to read and interpret technical documents + Excellent professional ethics, integrity, and ability to maintain confidential information **Physical Demands:** While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision. 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 . 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. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is 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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS 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/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1587551 **Updated:** 2024-12-27 06:14:33.811 UTC **Location:** Indianapolis-IN Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.