Scientist/Engineer
Bristol Myers Squibb
6 days ago
On-site
Summit, NJ
Other
Duties and Responsibilities:
- Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) using root cause analysis tools.
- Lead investigations and cross-functional investigation teams; close reports in a timely manner.
- Perform GEMBA walks with stakeholders to understand process steps and evaluate root cause analysis.
- Propose CAPAs, develop CAPA plans, and assure CAPA effectiveness.
- Assess impact/risk of proposed changes and develop mitigation strategies; may initiate change control documentation.
- Identify functional SMEs to support impact assessments during change management.
- Ensure investigations are completed timely; notify stakeholders of delays.
- Provide technical support for manufacturing investigations, CAPAs, and change controls as needed.
- Support deviation investigation defense during audits and site inspections.
- Handle complex issues with minimal guidance.
- Provide training to new investigation team members.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Support manufacturing and Quality Control testing of CAR T products as needed.
- Apply lean manufacturing / six sigma principles to continuously improve.
Required/Preferred Qualifications:
- Working experience in deviation investigations using root cause analysis tools.
- Working CAPA process experience with ability to identify and verify effectiveness.
- Technical writing skills; ability to collaborate cross-functionally.
- Ability to interpret/apply global regulatory and cGMP requirements; support health authority inspections.
- Knowledge of data trending/tracking; statistical analysis software a plus.
- Advanced problem-solving, prioritization, timeline management.
- Experience using electronic quality systems (eQRMs a plus).
- Hands-on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
Education and Experience:
- Bachelor’s degree in science or engineering (biochemistry/life sciences or related); advanced degree preferred.
- Minimum 3 years relevant experience in a health authority regulated environment.
- Biopharmaceutical manufacturing facility experience preferred (CAR T a plus).
Application Instructions:
- Contract assignment (100% onsite, Mon–Fri normal business hours).
- Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) using root cause analysis tools.
- Lead investigations and cross-functional investigation teams; close reports in a timely manner.
- Perform GEMBA walks with stakeholders to understand process steps and evaluate root cause analysis.
- Propose CAPAs, develop CAPA plans, and assure CAPA effectiveness.
- Assess impact/risk of proposed changes and develop mitigation strategies; may initiate change control documentation.
- Identify functional SMEs to support impact assessments during change management.
- Ensure investigations are completed timely; notify stakeholders of delays.
- Provide technical support for manufacturing investigations, CAPAs, and change controls as needed.
- Support deviation investigation defense during audits and site inspections.
- Handle complex issues with minimal guidance.
- Provide training to new investigation team members.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Support manufacturing and Quality Control testing of CAR T products as needed.
- Apply lean manufacturing / six sigma principles to continuously improve.
Required/Preferred Qualifications:
- Working experience in deviation investigations using root cause analysis tools.
- Working CAPA process experience with ability to identify and verify effectiveness.
- Technical writing skills; ability to collaborate cross-functionally.
- Ability to interpret/apply global regulatory and cGMP requirements; support health authority inspections.
- Knowledge of data trending/tracking; statistical analysis software a plus.
- Advanced problem-solving, prioritization, timeline management.
- Experience using electronic quality systems (eQRMs a plus).
- Hands-on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
Education and Experience:
- Bachelor’s degree in science or engineering (biochemistry/life sciences or related); advanced degree preferred.
- Minimum 3 years relevant experience in a health authority regulated environment.
- Biopharmaceutical manufacturing facility experience preferred (CAR T a plus).
Application Instructions:
- Contract assignment (100% onsite, Mon–Fri normal business hours).