Commissioning & Qualification Engineer

Responsibilities

• Lead and execute commissioning and qualification activities for new secondary and tertiary packaging equipment installations across four new packaging lines in Building 2
• Develop, author, review, and execute C&Q documentation including commissioning plans, commissioning protocols, test scripts, punch lists, and turnover packages
• Perform hands-on equipment walkdowns, system verifications, and commissioning checks directly on the manufacturing floor
• Manage punch list identification, tracking, and resolution through to system acceptance and turnover
• Collaborate with equipment vendors, engineering, construction, and operations teams to ensure systems are installed, functional, and commissioned to design specification
• Support and execute SAT (Site Acceptance Testing) activities for incoming packaging equipment
• Ensure all C&Q activities are performed in compliance with FDA, GMP, and applicable site and regulatory standards
• Apply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect real-world operational requirements
• Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of commissioned systems into GMP operations
• Maintain accurate and complete C&Q records in compliance with site documentation standards and data integrity requirements