Bristol Myers Squibb
Associate Director of Validation ,
Bristol Myers Squibb Location: Indianapolis, IN Employment Type: Full-time
Working with Us Challenging, meaningful, life‑changing work. At Bristol Myers Squibb, you’ll contribute to transforming patients’ lives through manufacturing and cell therapy innovation. Join high‑achieving teams, grow career opportunities, and balance flexibility with strong benefits.
Key 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.
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 document 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.
Education and Experience
Required: Bachelor’s degree in Engineering, Life Sciences, or related discipline.
Preferred: Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent).
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.
Skills and Qualifications
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.
Physical Demands
Ability to climb ladders and lift up to 25 lbs.
Frequent interaction within laboratory or manufacturing settings; PPE required in controlled environments.
Work Environment
Moderate noise levels.
Exposure to laboratory, pharmaceutical manufacturing, and radiopharmaceutical production areas.
Compensation Overview Indianapolis – RayzeBio – IN $164,838 – $199,745 FTE basis. Additional incentive cash and stock opportunities may be available. Final compensation will be decided based on demonstrated experience.
Benefits
Health Coverage – Medical, pharmacy, dental, and vision care.
Well‑being Support Programs – BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
Financial Well‑being – 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, survivor support.
Paid Time Off – US exempt employees flexible time off (unlimited, with manager approval, 11 paid national holidays). 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.
Global Shutdown – 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.
Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support. Applicants can request accommodations prior to accepting a job offer. Contact adastaffingsupport@bms.com.
Equal Employment Opportunity BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For additional information, visit careers.bms.com/eeo-accessibility.
Data Protection No payments, financial information, or social security numbers will be requested during the application or recruitment process. For more information, visit careers.bms.com/fraud-protection.
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Bristol Myers Squibb Location: Indianapolis, IN Employment Type: Full-time
Working with Us Challenging, meaningful, life‑changing work. At Bristol Myers Squibb, you’ll contribute to transforming patients’ lives through manufacturing and cell therapy innovation. Join high‑achieving teams, grow career opportunities, and balance flexibility with strong benefits.
Key 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.
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 document 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.
Education and Experience
Required: Bachelor’s degree in Engineering, Life Sciences, or related discipline.
Preferred: Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent).
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.
Skills and Qualifications
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.
Physical Demands
Ability to climb ladders and lift up to 25 lbs.
Frequent interaction within laboratory or manufacturing settings; PPE required in controlled environments.
Work Environment
Moderate noise levels.
Exposure to laboratory, pharmaceutical manufacturing, and radiopharmaceutical production areas.
Compensation Overview Indianapolis – RayzeBio – IN $164,838 – $199,745 FTE basis. Additional incentive cash and stock opportunities may be available. Final compensation will be decided based on demonstrated experience.
Benefits
Health Coverage – Medical, pharmacy, dental, and vision care.
Well‑being Support Programs – BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
Financial Well‑being – 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, survivor support.
Paid Time Off – US exempt employees flexible time off (unlimited, with manager approval, 11 paid national holidays). 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.
Global Shutdown – 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.
Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support. Applicants can request accommodations prior to accepting a job offer. Contact adastaffingsupport@bms.com.
Equal Employment Opportunity BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For additional information, visit careers.bms.com/eeo-accessibility.
Data Protection No payments, financial information, or social security numbers will be requested during the application or recruitment process. For more information, visit careers.bms.com/fraud-protection.
#J-18808-Ljbffr