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Packaging Validation Engineer

2 weeks ago

Greenville, SC, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Lead the packaging validation project, coordinating cross-functional efforts and ensuring alignment with project objectives, timelines, and regulatory requirements.
  • Develop and execute validation documentation (URS, risk assessments, FAT/SAT, IQ/OQ/PQ, and final reports) for packaging lines and related equipment, including fillers, cappers, labellers, conveyors, vision inspection, and serialization systems.
  • Manage communication between validation, engineering, and quality teams to drive efficient decision-making and issue resolution.
  • Oversee qualification of change parts, line configuration changes, and multiple bottle/cap presentations.
  • Provide hands-on support during commissioning and execution phases, including troubleshooting and deviation resolution.
  • Support process performance qualification (PPQ) activities and readiness for commercial production.
  • Ensure all validation deliverables comply with cGMP, FDA, and EU Annex 1 requirements, as well as internal procedures and the site's Validation Master Plan (VMP).
Requirements:
  • Bachelor's degree in engineering or Natural Sciences.
  • Experience in packaging validation for sterile or aseptic liquid operations.
  • Demonstrated experience leading validation projects or small technical teams.
  • Solid understanding of liquid filling systems, packaging automation, inspection technologies, and capping mechanisms.
  • Strong knowledge of GAMP 5, 21 CFR Part 11, and Annex 1.
  • Excellent communication, organization, and documentation skills, with the ability to effectively interact with clients, peers, and management.
  • bility to work independently and manage multiple priorities in a fast-paced, regulated environment.