Key Responsibilities

  • Participate in proposal preparation and budget development
  • Lead a team of process engineers and designers, delegating tasks and monitoring progress of all deliverables and activities, and mentoring and training entry-level engineers
  • Work closely with the project manager to insure scope, schedule, budget, change control, and quality parameters are met on the project
  • Overseeing the preparation of technical specifications for purchased equipment, as well as coordination with equipment suppliers and evaluation of suppliers’ proposals
  • Coordinate technical efforts between the process team and the architectural, piping, and automation teams on the project, as well as facility teams for civil, structural, electrical, HVAC, and environmental activities
  • Manage the client drivers for the project, which include capital cost, life-cycle cost, impact on current operations, quality, and schedule
  • Support business development efforts by acting as process lead in client presentations and meetings
  • Participate in vendor coordination meetings, factory acceptance testing and integration of third-party single-use componentry.
  • In certain instances, the lead process engineer will be asked to follow the project into the field, providing construction, commissioning, and startup support while leading a team of engineers

Skills / Qualifications

  • Bachelor’s degree in chemical or mechanical engineering, or pertinent degree and experience
  • 15+ years of progressive experience in process engineering design
  • Must have focused design experience in the chemical, pharmaceutical and biotechnology industries, especially in cell therapy, gene therapy, antibody, microbial or bulk vaccine processes, as well as plant and process utilities; Experience should include bulk manufacturing and/or fill/finish experience
  • Experience in the development and maintenance of all process deliverables, including: process flow diagrams, piping and instrument diagrams, process timelines, utility analysis and summary, priced equipment list, equipment data sheets and specifications as well as equipment bid evaluations, process descriptions, relief calculations, safety review documents, and instrumentation/automation sequences
  • Working knowledge of pharmaceutical process equipment materials including polymers.
  • Demonstrated understanding of interactions between Process design with MEP design efforts
  • Knowledge of system design, cGMPs, and applicable codes
  • Ability to collaborate with project team members and client entities, demonstrating the leadership capabilities to insure a successful project
  • Demonstrated experience working with equipment vendors to provide optimum solutions to equipment design that will meet or exceed client expectations
  • Capable of coordinating the process design with the piping model
  • Previous experience managing, developing and encouraging growth for entry-level engineers
  • Excellent written and oral skills are required
  • P.E. license is not required, but preferred