Process Engineer / Pharma Biologics Manufacturing

Pioneer Data Systems

Full-time - Mid Level

Administrative and Support Services

About the position

The Process Engineer will play a crucial role in the pharmaceutical manufacturing sector, focusing on the engineering of processes for large molecule biologics. This position involves defining the technical direction of complex projects and ensuring the successful startup of processes. The role is hybrid, allowing for a combination of in-office and remote work, and offers the potential for permanent employment after the contract period.

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 startup.

Requirements

• 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 into business solutions.
• Track record of successful program execution and team outcomes.
• The ability to lead and/or support multiple projects simultaneously.

Nice-to-haves

• PE Certificate preferred.
• FPX certification and Six Sigma and/or Lean experience are a plus.
• ISPE and/or ASME BPE active participation.

Benefits

• Participation in the company group medical insurance plan.