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Principal Process Engineer

2 months ago

Conshohocken, United States LanceSoft, Inc. Full time

Title: Senior Process Engineer

Location: Conshohocken, PA - Hybrid schedule (3 days onsite)

Duration: 14 months


Responsibilities:

  • Defines technical or scientific direction of programs composed of multiple complex projects
  • Engineers new and modifies existing processes to ensure right first-time process start up


Qualifications:

  • Minimum of a Bachelor's or equivalent University Degree is required; MS/MBA/Ph.D. is preferred
  • A minimum of 6+ years of process/plant engineering experience in GMP MFG large molecule biologics facilities.
  • Experience with upstream, downstream or utility process engineering
  • Must have experience with 2 or more of the following:
  • Upstream - Inoculum, Single Use Bioreactor, Wave Bioreactor, Perfusion Bioreactor, Centrifuge
  • Downstream - Chromatography, Ultrafiltration Diafiltration, In Line Dilution/Conditioning, Viral Filtration, Column Packing
  • Utility & Support - Media Prep, Buffer Prep, CIP, SIP, WFI, Process Gases, Caustic Dilution and Distribution, Clean Steam, Waste Treatment
  • Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities and operations.
  • Strong technical background in Process and Manufacturing engineering, manufacturing operations and financial fundamentals.
  • Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions
  • Track record of successful program execution and team outcomes
  • The ability to lead and/or support multiple projects simultaneously
  • PE Certificate preferred
  • FPX certification and Six Sigma and/or Lean experience are a plus
  • ISPE and/or ASME BPE active participation