Bristol Myers Squibb Engineer - Investigations in Hopewell, New Jersey

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

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.