Validation Engineer II

Bristol Myers Squibb • Indianapolis, IN

8d • Onsite

About The Position

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/ Summary The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer II will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the use of highly specialized facility, utility, analytical, and process equipment. The position will utilize a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations. Additional responsibilities may include the onboarding of new technologies, process development, GMP operations support, deviation investigation, CAPA management, continuous improvement projects, and future facility expansion projects.

Requirements

• BS or MS in scientific related field or equivalent work experience
• 2-5 years of experience in Radiopharmaceutical or injectable GMP manufacturing environment
• 2-5 years of validation experience within a GMP environment
• Good technical writing skill-set
• Solid understanding of regulatory guidelines for validation and risk management
• Must possess an independent mindset and tenacity
• Highly motivated and organized professional with strong interpersonal and communication skills.
• Proven experience working with teams in a GMP environment.
• Multi disciplined engineer with GMP experience
• Excellent professional ethics, integrity, and ability to maintain confidential information.

Responsibilities

• Work with the project team and/or General Contractor as required to support the commissioning and validation of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility.
• Develop and implement the CQV strategies for the GMP spaces including but not limited to office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Work with consultant(s) as required to support the implementation and execution of the CQV program.
• Support the engineering, QC, and Operations team as required to improve and implement new processes
• Provide validation support for day-to-day development and GMP operations
• Provide engineering and operational support as required
• Expand expertise in additional areas of validation (process validation, QC assets, CSV, cleaning validation, etc)
• Own and manage a specific area of validation (i.e. process validation, QC assets, CSV, cleaning validation, etc)
• Apply technical knowledge and abilities to investigate manufacturing deviations
• Review data and documentation to support investigations
• Own and drive projects and continuous improvement efforts
• Draft GMP documentation including but not limited to SOP’s, Forms, Protocols, Technical Documents, Reports, Deviations, CAPAs, Change Controls and reports.
• Support Health Authority Inspections
• Maintain department KPIs related to performance
• Mentor and cross-train other team members
• Execute and provide support executing equipment and process validations as necessary.

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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level