Associate Director of Validation position at Bristol Myers Squibb.| United States Of America

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Bristol Myers Squibb Associate Director of Validation

Experience: 8-years

Pattern: full-time

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Associate

Indianapolis -..........United States Of America

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/ The Associate Director of Validation is responsible for leading the validation function to ensure that manufacturing facilities, utilities, equipment, processes, and computerized systems comply with regulatory and company standards for pharmaceutical/radiopharmaceutical production. This role oversees validation activities from initial planning through execution, manages a cross-functional team, and ensures alignment with regulatory requirements (cGMP, FDA, USP, and other relevant bodies). The ideal candidate has extensive experience in validation within radiopharmaceutical or pharmaceutical manufacturing and a strong technical background in process and facility qualification. Key Responsibilities Lead, plan, and execute the validation strategy for manufacturing facilities, utilities, equipment, process technologies, and computerized systems. Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new or expanded manufacturing capabilities (facility, equipment, utilities, and processes). Direct and coordinate multidisciplinary validation teams, including hiring, mentoring, and professional development of validation personnel. Collaborate closely with site leadership, engineers, QA/Quality, and external vendors and contractors to ensure timely and compliant validation delivery for expansion, renovation, and site build projects. Ensure adherence to budget, schedule, and quality standards within validation scope across all site projects Review and approve technical documentation, validation protocols, risk assessments, and qualification deliverables. Manage and resolve deviations, CAPAs, and change controls related to validation and qualification activities. Support regulatory inspections, audits, and responses by ensuring site validation compliance and documentation integrity. Lead validation efforts to support site/facility strategic initiatives, new technology integration, and global harmonization as needed. Drive continuous improvement of validation processes for enhanced site reliability and regulatory compliance. Lead and mentor the deviation investigations team for the site. Uphold all safety standards; ensure safe handling of radioactive materials and hazardous equipment throughout validation activities. Education and Experience Required: Bachelor’s degree in Engineering, Life Sciences, or a related discipline. Preferred: Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent), Minimum 8 years' experience in validation within pharmaceutical/radiopharmaceutical manufacturing, including large-scale capital project support (>$10M). Demonstrated understanding and hands-on experience with radiopharmaceutical or pharmaceutical validation systems and compliance. Direct experience managing validation or multidisciplinary project teams and external contractors. Skills and Qualifications Strong knowledge of pharmaceutical validation practices, including cGMP and FDA/USP/OSHA regulatory requirements. Expert understanding of facility, utility, aseptic processing, and fill/finish equipment validation. Advanced proficiency in authoring and managing validation documentation (master plans, risk assessments, protocols, and reports). Familiarity with qualification of computerized systems and data integrity best practices. Solid background in vendor management, contract review, and cost controls within validation scopes. Excellent written, verbal, stakeholder, and team leadership communication skills. Proficient in MS Office Suite, validation software/applications, and computerized maintenance management systems (CMMS). Willingness to work in radioactive environments and follow strict safety requirements. Ability to travel and support validation at multiple domestic or international sites. Physical Demands Ability to climb ladders and lift up to 25 lbs. Frequent interaction within laboratory or manufacturing settings; PPE required in controlled environments. Work Environment Moderate noise levels. Exposure to laboratory, pharmaceutical manufacturing, and radiopharmaceutical production areas. #RayzeBio 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: $164,838 - $199,745
 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: T he 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. R1595528 : Associate Director of Validation

Associate Director of Validation job opportunity at Bristol Myers Squibb.

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