Senior Process Engineer

4 days ago


King of Prussia, Pennsylvania, United States SK pharmteco Full time
Job Title: Senior Process Engineer

Join SK pharmteco as a Senior Process Engineer and play a key role in managing the manufacturing and production systems for cell and gene therapy operations.

Key Responsibilities:
  • Manage engineering responsibilities and report progress to management for engineering testing, commissioning, and qualification activities.
  • Responsible for all aspects of engineering design and installation by working with external supply partners, design firms, and contractors.
  • Ensure all project documentation is accurate and up-to-date (P&lDs, mechanical system drawings, automation documentation, etc.).
  • Organize and lead technical aspects of large-size operational and technology transfer projects, including scope, schedule, and coordination of activities.
  • Compile and review equipment Engineering Turnover Packages (EToPs) for executed projects.
  • Responsible for ensuring all equipment is walked down and revised for all types of engineering drawings.
  • Work with cross-functional groups to develop requirements and recommendations for system/facility modifications.
  • Lead troubleshooting and remediation of exceptions found during process operations and technology transfers.
  • Accountable for all phases of the engineering lifecycle.
  • Define all aspects of project scope and project activities.
  • Develop and mentor junior engineers on Good Engineering Practices (GEP).
Requirements:
  • B.S. or M.S. in Engineering or a Life/Physical Science with relevant work experience (Chemical Engineering preferred, others considered).
  • 5-8+ years of experience investigating, developing, and implementing new manufacturing processes and improving existing manufacturing processes.
  • Working knowledge of design specification and operation of bioprocess equipment, clean utilities, GMP facilities, and automation.
  • Owner of med-large process or portion of larger process with guidance from senior department leadership.
  • Willing and able to execute hands-on, clean room manufacturing support where necessary.


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