Process Engineer
: Job Details :

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 4+ 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