Process Engineer

Huntersville, NC

Company Name :Ibainfotechinc

Type : contract

Primary Skills : FAT, SAT, IQ/OQ

Location : Huntersville

CTC : DOE

Job Description:

Responsibilities

  • Provide expertise in process engineering, design, and on-going improvements for facility startup and manufacturing activities
  • Support Single-Use (SU) program development and execution in collaboration with internal and external partners
  • Author and/or review process descriptions, technical reports, and impact assessments/root cause investigations
  • Support equipment commissioning, training, and validation activities
  • Provide on-the-floor support to implement improvements for the process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and equipment troubleshooting for GMP manufacturing
  • Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems
  • Comply with GMPs, safety, and other policies
  • Keep current with advances in technologies; evaluate and recommend new technologies that will be useful in expanding and enhancing platform processes; help coordinate deployment across the Audentes manufacturing network as appropriate
  • Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation
  • Support data management including the trending of process outcomes and in-process data to enhance process understanding and improvements
  • Interact closely with multiple interdisciplinary groups (Manufacturing, Quality Assurance, Quality Control, Process Development, Facilities, Validation, Automation, etc.)

 

Required Qualifications

  • BS or MS in Chemical/Mechanical/Biological Engineering or Life Sciences plus 5+ years of experience in life sciences, including 3+ years as a Processor Manufacturing Engineer
  • Knowledge of equipment and systems used for upstream and/or downstream unit operations
  • Capable of working independently at times, with minimal supervision, and managing multiple projects
  • Sense of urgency and enthusiasm
  • Demonstrated success and desire to work within a fast-paced environment under challenging timelines
  • Strong attention to detail supported by excellent time management and organizational skills
  • Proficiency with MS Office (Excel, PowerPoint, Word, Project, and Visio)
  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

 

Preferred Qualification

  • Experience with scale-up/scale-down and tech transfer
  • Experience with single-use equipment and systems including understanding the effects of leachable ad extractable chemicals on process performance and product quality
  • Working knowledge of cGMPs and good documentation practices (GDP)
  • Experience in a design firm or consulting setting
  • Experience with process and equipment design engineering such as hydraulic calculations, equipment sizing, process simulations, Heat and Material Balances (H&MB), Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), and User Requirement Specification (URS) development
  • Experience leading or supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ