Bristol Myers Squibb

Bristol Myers Squibb

Lead Validation Engineer

Indianapolis - RayzeBio - IN · Part-time

Sponsorship not specified$124k-$151kDetected 9 hours ago
AccessibilityProject ManagementExcelProcess ImprovementGMPLeadershipCommunicationCollaborationProblem SolvingMentoringPublic SpeakingWriting

About the role

  • Indianapolis -

Responsibilities

  • Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs.
  • Partner with project teams, consultants, contractors, Quality, Engineering, QC, and Operations to deliver validation milestones aligned with business and compliance objectives.
  • Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments.
  • Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation.
  • Review and approve validation documents including SOPs, forms, protocols, technical reports, deviations, CAPAs, change controls, and summary reports.
  • Lead deviation investigations and support root cause analysis, corrective actions, and preventive actions related to validation and manufacturing systems.
  • Drive continuous improvement projects that enhance compliance, efficiency, and operational readiness.
  • Mentor, coach, and develop validation engineers and cross-functional team members.
  • Support regulatory inspections and internal audits by presenting validation strategies, rationale, and supporting documentation.

Requirements

  • 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.
  • Support onboarding of new technologies, facility modifications, and expansion projects as required.

Skills

  • Strong technical writing and document review skills.
  • Deep understanding of regulatory expectations for validation, lifecycle management, and risk management.
  • Strong leadership, decision-making, and problem-solving skills.
  • Ability to work independently while effectively influencing cross-functional teams.
  • Excellent communication, organization, and project management capabilities.
  • Proven ability to prioritize multiple initiatives in a fast-paced GMP environment.
  • Applies AI to improve team execution and decision‑making

Compensation

  • 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.

Company info

  • 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.
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This listing is sourced directly from Bristol Myers Squibb's careers page and normalized into a canonical job model.