Manager Process Engineering

Manager Process Engineering

Manager Process Engineering

Accentuate Staffing is working with a growing biotechnology company in the Raleigh area looking to fill an immediate opportunity.  The Manager of Process Engineering is a direct hire need!


  • Utilizing sound engineering principles to develop manufacturing process capabilities to ensure adequate material supplies to meet project objectives
  • Coordination of the process engineering group to execute continuous improvement projects including the evaluation and implementation of process changes to improve product quality, decrease cost, and improve manufacturing efficiencies
  • Designing and executing detailed experimental plans
  • Lead initiation and closure of Quality System Elements supporting manufacturing operations including Change Control, CAPA and event investigation.
  • Maintaining accurate, detailed documentation throughout all phases of process development
  • Ensuring effective communication within the operations team and across all functions that engage in development and production activities
  • Supervising the process engineering team staff, including integration of new hires, coordination of production staff and employee development
  • Identify, troubleshoot, and resolve technical issues associated with manufacturing operations with input from other technical functions
  • Creating a development production environment using current standards in Current Good Manufacturing Practices including lean operations, continuous improvement and monitoring and trending of operation efficiency


  • BS/MS in a technical discipline (Engineering preferred)
  • 7+ years’ experience in process development or manufacturing operations in Pharmaceutical, Medical Device, or other FDA regulated industry required
  • 2+ years’ experience in employee management in a cGMP environment
  • Demonstrated aptitude for ‘hands-on’ experimentation with an exemplary history as a “self-starter”
  • Mastery of CGMP quality system elements including change control, root cause investigation and CAPA
  • Demonstrated experience in DOE including experimental design, execution, data analysis and results summation
  • Experience with early-stage product development and scale up in a cGMP environment is preferred
  • Ability to summarize data and results for business and technical audiences
  • Outstanding professional-interpersonal and relationship building skills, and influencing and negotiating skills
  • Must enjoy and thrive in an entrepreneurial environment

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