Bristol-Myers Squibb Company

Engineer - Investigations

Location
Hopewell, NJ, US
Posted
Apr 17, 2018
Ref
R1505379
Required Education
Bachelors Degree
Position Type
Full time

Summary:

• The Engineer will serve as the manufacturing lead for the Deviation Management System
• The Engineer will support the Hopewell Clinical Manufacturing Upstream and Downstream Processing group on a daily basis, as well as lead or contribute to strategic projects.
• The Engineer will Identify opportunities Continuous Improvement and Operational Excellence

Responsibilities:

  • The Engineer will serve as the manufacturing lead for the Deviation Management System
    • Function as a certified Lead Investigator for Deviation Investigations
    • Perform Event Reviews and Initial Risk Assessments
    • Lead Investigation teams for High and Medium Risk Deviation Investigations
    • Complete documentation for Low Risk Deviations
    • Perform Root Cause Analysis and Product Impact assessments
    • Use appropriate Investigation tools necessary to drive an investigation team to root cause
    • Determine and Implement corrections, corrective actions, and preventive actions to prevent recurrence
    • Determine and execute effectiveness plans
    • Author relevant sections of Investigation Documentation
    • Present investigations to the Senior Management Investigation Review Board for endorsement
    • Train, coach and mentor other Lead Investigators and Quality Lead Coordinators
    • Function as a Deviation Management System subject matter expert during audits
    • Represent Hopewell by attending monthly Global Investigation team meetings
    • Support or author revisions to Local SOPs pertaining to the Deviation Management System
  • The Engineer will support the Hopewell Clinical Manufacturing Upstream and Downstream Processing group on a daily basis, as well as lead or contribute to strategic projects.
    • Author and/or approve Raw Materials and Consumables Specifications
    • Author documentation for Vendor Change Notifications and Vendor Complaints
    • Author and Complete Change Controls
    • Perform process monitoring and author campaign summary and bioburden/endotoxin reports
    • Follow cGMP requirements, demonstrate commitment to balancing speed and quality/compliance

 

 

  • The Engineer will Identify opportunities Continuous Improvement and Operational Excellence
    • Lead or support projects using DMAIC tools or the PDCA cycle