Bristol Myers Squibb · 2 weeks ago
Validation Engineer II
Indianapolis, IN
Full-time
Onsite
Entry, Mid Level
$96K/yr - $117K/yr
2+ years expBristol Myers Squibb is a leading biotechnology company dedicated to transforming patients' lives through science. The Validation Engineer II will support the Radiopharmaceutical facility and GMP operations, focusing on drafting and executing commissioning, qualification, and validation documents while utilizing various engineering disciplines to advance from construction to clinical development and GMP commercial operations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
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
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
2026-01-09
2026-01-08
2026-01-07
Company data provided by crunchbase