Bristol Myers Squibb · 2 days ago
Sr Validation Engineer
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$108K/yr - $131K/yr
5+ years expBristol Myers Squibb is a dynamic biotechnology company focused on improving survival of people with cancer. The Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations, responsible for the development, execution, and management of commissioning, qualification, and validation documents and protocols.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Serve as validation subject matter expert for the commissioning and qualification of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility, including isolator-based aseptic processes
Lead the strategy and implementation of CQV programs for GMP spaces: office, warehouse, development, quality control, sterility/microbiology, and GMP production, with emphasis on isolator and containment technologies
Direct and coordinate consultant(s) and project teams in the execution of validation activities and continuous improvement initiatives
Partner cross-functionally with Engineering, QC, and Operations to develop and implement new processes and onboarding of new technologies, including advanced isolator systems
Provide senior-level validation oversight and support for ongoing development and GMP manufacturing operations
Guide, mentor, and cross-train team members to broaden validation capabilities, including process validation, cleaning validation, CSV, and QC asset validation
Own and drive key validation areas and projects, establishing and maintaining best practices for isolator technology and sterile operations
Lead complex deviation investigations, data reviews, CAPA management, change controls, and ensure robust technical documentation
Author, review, and approve GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPA, and change controls
Support and represent the validation function during Health Authority inspections and audits
Monitor and report on department KPIs to drive performance improvement
Execute and provide technical support for equipment and process validation, including hands-on experience with isolator-based sterile filling and process systems
Qualification
Required
BS or MS in a scientific discipline or engineering field (advanced degrees preferred)
Minimum 5 years of experience in radiopharmaceutical or injectable GMP manufacturing environment
Minimum 5 years of validation experience in GMP environments, with direct isolator technology and aseptic processing experience required
Advanced technical writing and documentation skills
Expert knowledge of regulatory guidelines for validation, risk management, and isolator-based processes
Proven leadership capabilities, independent mindset, and effective problem-solving abilities
Highly organized professional with exceptional communication, interpersonal, and mentoring skills
Track record of leading teams and cross-functional projects in GMP environments
Strong multi-disciplinary engineering background, with specific expertise in isolator systems for sterile manufacturing
High professional ethics, integrity, and ability to maintain confidential information
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.
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
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
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase