Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Process Engineer

Raleigh, NC, US • Posted 60+ days ago • Updated 4 days ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Quality Assurance
  • Project Engineering
  • Manufacturing Operations
  • Mechanical Engineering
  • Chemical Engineering
  • Biomedical Engineering
  • Manufacturing Engineering
  • Industrial Engineering
  • Good Manufacturing Practice
  • Communication
  • Management
  • Process Engineering
  • Pharmaceutics
  • Startups
  • IQ
  • OQ
  • PQ
  • Process Optimization
  • GMP
  • ROOT
  • Corrective And Preventive Action
  • Collaboration
  • Manufacturing
  • Technical Writing

Summary

Responsibilities:
  • Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing.
  • Working closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will ensure cartridge filling processes consistently meet production, quality, and regulatory objectives while supporting the successful startup of new manufacturing operations.
  • Direct experience supporting cartridge filling lines is required. Candidates with experience limited to syringe filling will not be considered.

Requirements:
  • Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
  • 5+ years of pharmaceutical manufacturing experience, preferably supporting sterile injectable operations.
  • Hands-on cartridge filling experience is required.
  • Strong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles.
  • Experience supporting equipment validation, process qualification, and manufacturing startup activities.
  • Excellent troubleshooting, communication, and technical writing skills.

Most Important Skills Needed:
  • Direct cartridge filling line experience (Required)
  • Process Engineering within sterile pharmaceutical manufacturing
  • septic filling operations
  • Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)
  • Process optimization and manufacturing troubleshooting
  • GMP manufacturing experience
  • Root cause investigations, CAPA, and deviation support
  • Cross-functional collaboration with Manufacturing, Validation, Automation, and Quality
  • Technical documentation, engineering studies, and protocol development
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 608184c7be411686d2bfc8234f325430
  • Posted 30+ days ago
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