Associate Director of Validation
Bristol-Myers Squibb
Associate Director of Validation
Job Description
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. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Required: Bachelor's degree in Engineering, Life Sciences, or a 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. 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.
About the Role/Company
- Supporting People with Disabilities
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 (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
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related discipline
Preferred Qualifications
- 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)
Skills Required
- 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
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to travel and support validation at multiple domestic or international sites
- Ability to climb ladders and lift up to 25 lbs
Locations
- Indianapolis RayzeBio, India
Salary
Estimated Salary Rangemedium confidence
1,200,000 - 2,400,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated understanding and hands-on experience with radiopharmaceutical or pharmaceutical validation systems and complianceintermediate
- Direct experience managing validation or multidisciplinary project teams and external contractorsintermediate
- Strong knowledge of pharmaceutical validation practices, including cGMP and FDA/USP/OSHA regulatory requirementsintermediate
- Expert understanding of facility, utility, aseptic processing, and fill/finish equipment validationintermediate
- Advanced proficiency in authoring and managing validation documentation (master plans, risk assessments, protocols, and reports)intermediate
- Familiarity with qualification of computerized systems and data integrity best practicesintermediate
- Solid background in vendor management, contract review, and cost controls within validation scopesintermediate
- Excellent written, verbal, stakeholder, and team leadership communication skillsintermediate
- Proficient in MS Office Suite, validation software/applications, and computerized maintenance management systems (CMMS)intermediate
- Willingness to work in radioactive environments and follow strict safety requirementsintermediate
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related discipline (experience)
Preferred Qualifications
- Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent) (experience)
- Minimum 8 years' experience in validation within pharmaceutical/radiopharmaceutical manufacturing, including large-scale capital project support (>$10M) (experience)
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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Associate Director of Validation @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs
Associate Director of Validation
Bristol-Myers Squibb
Associate Director of Validation
Job Description
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. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Required: Bachelor's degree in Engineering, Life Sciences, or a 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. 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.
About the Role/Company
- Supporting People with Disabilities
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 (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
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related discipline
Preferred Qualifications
- 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)
Skills Required
- 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
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to travel and support validation at multiple domestic or international sites
- Ability to climb ladders and lift up to 25 lbs
Locations
- Indianapolis RayzeBio, India
Salary
Estimated Salary Rangemedium confidence
1,200,000 - 2,400,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated understanding and hands-on experience with radiopharmaceutical or pharmaceutical validation systems and complianceintermediate
- Direct experience managing validation or multidisciplinary project teams and external contractorsintermediate
- Strong knowledge of pharmaceutical validation practices, including cGMP and FDA/USP/OSHA regulatory requirementsintermediate
- Expert understanding of facility, utility, aseptic processing, and fill/finish equipment validationintermediate
- Advanced proficiency in authoring and managing validation documentation (master plans, risk assessments, protocols, and reports)intermediate
- Familiarity with qualification of computerized systems and data integrity best practicesintermediate
- Solid background in vendor management, contract review, and cost controls within validation scopesintermediate
- Excellent written, verbal, stakeholder, and team leadership communication skillsintermediate
- Proficient in MS Office Suite, validation software/applications, and computerized maintenance management systems (CMMS)intermediate
- Willingness to work in radioactive environments and follow strict safety requirementsintermediate
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related discipline (experience)
Preferred Qualifications
- Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent) (experience)
- Minimum 8 years' experience in validation within pharmaceutical/radiopharmaceutical manufacturing, including large-scale capital project support (>$10M) (experience)
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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Associate Director of Validation @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs