Lead Validation Engineer

Bristol Myers Squibb • Indianapolis, IN

4d • $124,449 - $150,803 • Onsite

About The Position

The Lead Validation Engineer will support the Radiopharmaceutical facility and GMP operations in Indianapolis and serve as a technical leader for commissioning, qualification, and validation activities. This role is responsible for leading the drafting, review, and execution of commissioning, qualification, and validation documents and protocols supporting highly specialized facility, utility, analytical, and process equipment. The position applies broad engineering and GMP knowledge to support the transition from construction to clinical development and commercial operations, while also providing leadership in process improvement, deviation investigation, CAPA management, new technology implementation, and future expansion initiatives.

Requirements

• BS or MS in a scientific or engineering discipline, or equivalent work experience.
• 5+ years of experience in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment.
• 5+ years of validation experience within a GMP-regulated environment.
• Demonstrated experience leading complex validation programs and cross-functional initiatives.
• 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.
• Broad validation knowledge across areas such as process validation, cleaning validation, computer system validation, equipment qualification, and QC assets.
• High level of professional ethics, integrity, and ability to maintain confidential information.
• Applies AI to improve team execution and decision‑making

Nice To Haves

• Prior experience mentoring engineers or leading project workstreams is strongly preferred.

Responsibilities

• Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs.
• Develop, implement, and continuously improve commissioning, qualification, and validation strategies for GMP and non-GMP spaces including office, warehouse, development, quality control, sterility/microbiology, and production areas.
• 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.
• Track and communicate departmental KPIs, project status, risks, and resource needs to leadership.
• Support onboarding of new technologies, facility modifications, and expansion projects as required.

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: Senior
• Education Level: Associate degree