Associate Manufacturing Systems Engineer I

What you'll do

• Lead the development and implementation of the site's validation strategy.
• Author and manage critical documents including Validation Master Plans and equipment qualification protocols.
• Execute and oversee autoclave performance qualification, cleaning validation, and maintenance activities.
• Manage technical results for the commissioning and qualification of manufacturing process equipment.
• Develop and review specialized documentation for cleaning characterization and inactivation reports.
• Coordinate with cross-functional teams to ensure all corporate validation requirements are met.
• Drive continuous improvement initiatives for site and network validation processes.

What we're looking for

• High school diploma or GED and 6 years of Manufacturing or Operations experience.
• Associate’s degree and 4 years of Manufacturing or Operations experience.
• Technical writing and presentation skills to collaborate with technical and senior management staff (preferred).
• Proficiency using Kneat, CDOCs, Laboratory Inventory Management System, and Pi Sample Management lifecycle (preferred).
• Ability to gain expertise in equipment qualification and cleaning validation for a biologics facility (preferred).
• Ability to gain expertise in reviewing/approving validation protocols and reports (preferred).
• Demonstrated ability to read P&IDs (preferred).