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Senior Process Engineering Specialist

2 months ago

Holly Springs North Carolina, United States Fujifilm Full time

Position Summary:


A Senior Process Engineering Specialist offers advanced engineering guidance with minimal oversight, concentrating on aligning client processes with current facility designs and identifying equipment and facility deficiencies for Drug Substance (DS) and Drug Product (DP) operations.

This position advocates for the advancement of engineering, manufacturing, and facility technologies, engages in industry discussions, and delivers technical engineering knowledge for the design, installation, and modification of new processing equipment and existing facilities.

Key Responsibilities:

  • Acts as a technical authority in evaluating client facility compatibility and designing processes for equipment, facilities, and operational capabilities.
  • Oversees assessments and feasibility analyses for potential new and enhanced capabilities related to equipment and manufacturing.
  • Conducts engineering studies to validate process compatibility with plant operations for new and modified processes.
  • Provides design expertise and guidance for major projects or other initiatives.
  • Leads capital expenditure estimations for equipment.
  • Assists in the development of procurement documentation in collaboration with Project Engineering.
  • Identifies deficiencies, offers recommendations, and drives the implementation of enhancements within the Drug Substance (DS) and Drug Product (DP) manufacturing sectors.
  • Collaborates with Process Engineering/Science teams to pinpoint process optimizations and potential bottlenecks.
  • Engages with senior internal and external stakeholders on significant issues and cross-functional coordination as necessary.
  • Delivers regular updates to senior management on strategic projects, key technical initiatives, facility compatibility, and investments.
  • Serves as a subject matter expert (SME) for process equipment and technologies, including upstream and downstream processes.
  • Aids in site expansion project planning and future design considerations.
  • Facilitates the transition into technology transfer, including detailed mass balance, equipment flow diagrams, and technical consultation.
  • Provides support to Program Management, Manufacturing, Technical Operations, EH&S, etc., regarding new client processes and equipment as required.
  • Performs other assigned duties as necessary.
Qualifications:

  • Bachelor’s degree in Engineering or a related discipline with 8 years of relevant engineering or technical experience; or


  • Master’s degree in Engineering or a related discipline with 6 years of relevant engineering or technical experience.


  • Proficiency with Drug Substance (DS) or Drug Product (DP) process equipment and unit operations.
Preferred Qualifications:

  • Previous experience in a cGMP environment or another highly regulated sector.

Fujifilm is an Equal Opportunity Employer. All qualified candidates will be considered for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.


Physical Requirements:

Physical Demands:
May require respiratory protection. Will work in Mechanical/Production areas that may necessitate hearing protection. Must be able to operate a motor vehicle or Powered Industrial Truck. Requires the ability to discern audible cues and perform tasks with corrected vision, including color distinction.

Working Environment:
Must be able to ascend or descend ladders, scaffolding, and ramps. Ability to stand or sit for extended periods and conduct repetitive motions is required. Must be capable of operating machinery and moving objects as necessary.