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Home›Careers›Production Engineer, Sterile Operations

Production Engineer, Sterile Operations

Manufacturing · Alexandria · Full-time · Mid-level

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ManufacturingProduction Engineer, Sterile Operations
←Other roles
LocationAlexandria
TypeFull-time
LevelMid-level

Role Overview

Support the daily operation and continuous improvement of Pharco's sterile injectables fill-finish lines. Working within an FDA-inspected, aseptic manufacturing environment, you will troubleshoot process deviations, drive OEE improvements, and ensure full GMP compliance.

Key Responsibilities

  • Oversee fill-finish operations for liquid vials, ampoules, and lyophilised products
  • Investigate process deviations and implement CAPA with root-cause analysis
  • Collaborate with QA on batch record review and release documentation
  • Support equipment qualification (IQ/OQ/PQ) and annual product reviews
  • Identify and lead Lean/Six Sigma improvement projects on the production floor

Requirements

  • B.Sc. in Pharmaceutical Engineering, Chemical Engineering, or equivalent
  • 3+ years in sterile pharmaceutical manufacturing
  • Hands-on experience with aseptic filling equipment and isolator technology
  • Solid understanding of cGMP, FDA 21 CFR Part 211, and EU Annex 1
  • Strong analytical and problem-solving skills

Nice to Have

  • Lean Six Sigma Green Belt or higher
  • Experience with lyophilisation cycle development
  • Exposure to FDA or EMA inspections
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