Bristol Myers Squibb · 3 days ago
Associate Director of Validation
Indianapolis, IN
Full-time
Onsite
Lead/Staff, Director/Executive
$165K/yr - $200K/yr
8+ years expBristol Myers Squibb is a dynamic biotechnology company focused on improving survival rates for cancer patients through innovative drug development. The Associate Director of Validation will lead the validation function to ensure compliance with regulatory standards in pharmaceutical production, overseeing validation activities and managing a cross-functional team.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead, plan, and execute the validation strategy for manufacturing facilities, utilities, equipment, process technologies, and computerized systems
Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new or expanded manufacturing capabilities (facility, equipment, utilities, and processes)
Direct and coordinate multidisciplinary validation teams, including hiring, mentoring, and professional development of validation personnel
Collaborate closely with site leadership, engineers, QA/Quality, and external vendors and contractors to ensure timely and compliant validation delivery for expansion, renovation, and site build projects
Ensure adherence to budget, schedule, and quality standards within validation scope across all site projects
Review and approve technical documentation, validation protocols, risk assessments, and qualification deliverables
Manage and resolve deviations, CAPAs, and change controls related to validation and qualification activities
Support regulatory inspections, audits, and responses by ensuring site validation compliance and documentation integrity
Lead validation efforts to support site/facility strategic initiatives, new technology integration, and global harmonization as needed
Drive continuous improvement of validation processes for enhanced site reliability and regulatory compliance
Lead and mentor the deviation investigations team for the site
Uphold all safety standards; ensure safe handling of radioactive materials and hazardous equipment throughout validation activities
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related discipline
Minimum 8 years' experience in validation within pharmaceutical/radiopharmaceutical manufacturing, including large-scale capital project support (>$10M)
Demonstrated understanding and hands-on experience with radiopharmaceutical or pharmaceutical validation systems and compliance
Direct experience managing validation or multidisciplinary project teams and external contractors
Strong knowledge of pharmaceutical validation practices, including cGMP and FDA/USP/OSHA regulatory requirements
Expert understanding of facility, utility, aseptic processing, and fill/finish equipment validation
Advanced proficiency in authoring and managing validation documentation (master plans, risk assessments, protocols, and reports)
Familiarity with qualification of computerized systems and data integrity best practices
Solid background in vendor management, contract review, and cost controls within validation scopes
Excellent written, verbal, stakeholder, and team leadership communication skills
Proficient in MS Office Suite, validation software/applications, and computerized maintenance management systems (CMMS)
Willingness to work in radioactive environments and follow strict safety requirements
Ability to travel and support validation at multiple domestic or international sites
Ability to climb ladders and lift up to 25 lbs
Frequent interaction within laboratory or manufacturing settings; PPE required in controlled environments
Preferred
Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent)
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
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