Process Engineer

4 days ago

Durham, North Carolina, United States BioFire Diagnostics Full time
Job Summary

We are seeking a highly skilled Process Engineer to join our team at BioFire Diagnostics. As a Process Engineer, you will be responsible for managing and leading engineering projects at our Durham site.

Key Responsibilities
  • Manage selection and review of vendors for BACT/ALERT production
  • Ensure product specifications are up to date and can be reasonably adhered to
  • Participate in vendor performance reviews
  • Research and evaluate new vendors as required
  • Evaluate cost reduction opportunities along with Purchasing
  • Create clear and concise capital and expense reports
  • Provide supporting facts and documentation to support project deliverables
  • Monitor progress of projects to ensure they move at the planned pace
  • Subject Matter Expert for Commissioning, Qualification and Validation (CQV) activities
  • Develop and maintain validation plans
  • Develop and maintain system lifecycle documentation
  • Develop and execute CQV testing protocols
  • Maintain validation content oversight, provide guidance, and create draft validation master templates
  • Provide support to Quality Validation Department for equipment and process periodic reviews
  • Provide support in FDA, ISO, customer and other inspections and audits
  • Lead and participate in Change Management for Engineering Department
  • Actively participate in sites Change Review Board (CRB) for the Engineering Department
  • Manage and/or lead change controls related to scope of work
  • Execute assigned projects or scope of work
  • Manage project schedules as assigned
  • Work in a team environment to complete projects
  • Coordinate or provide training during implementation of assigned projects
  • Monitor equipment performance
  • Review OEE results, analyze data, and implement improvements as required
  • Support MFG equipment and processes as required
  • Review in-process scrap and act to improve as required
Requirements
  • Bachelor's Degree with a minimum 2 years of experience within a manufacturing environment with direct experience in Commissioning, Qualification and Validation
  • Minimum 3 years working in a cGMP environment required (ISO/FDA regulated preferred)
  • Demonstrated ability to exercise leadership, diplomacy, and problem-solving skills when coordinating and working within all levels of the organization
  • Basic Computer Skills required; must be experienced and proficient in the use of: Microsoft Office tools (specifically Word & Excel)
  • Advanced use of MS Word preferred
  • Excellent documentation and communication skills (written & verbal)
  • Position requires strong attention to detail and GMP experience (including knowledge of change control, validation, and commissioning processes)
  • Ability to work successfully autonomously, as an active contributor on a team
  • Experienced with equipment change control and standard operation procedures (generation/revision)

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