We are looking for an experienced Commissioning & Qualification (C&Q) Engineer to join our team in support of a major capital expansion project involving the installation of four new packaging lines.
This is a hands-on C&Q role embedded within a pharmaceutical secondary and tertiary packaging operation for final drug product.
This is not a validation role we are looking for a true C&Q professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a regulated pharmaceutical environment.
You will be responsible for leading and executing commissioning and qualification activities across new packaging equipment installations, ensuring all systems are built, installed, and functionally verified to specification and ready for handover to GMP manufacturing operations.
Roles & 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
Experience:
Experienced Commissioning & Qualification (C&Q) professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a regulated pharmaceutical environment
Experience supporting pharmaceutical secondary and tertiary packaging operations for final drug product
Hands-on experience in equipment commissioning, system turnover, and manufacturing floor execution
Knowledge of FDA, GMP, and applicable site and regulatory standards
Numbers & Facts
Location
New Albany, OH
Skills
Acceptance Testingunmatched
Biotech and Pharmaceuticalunmatched
C Programming Languageunmatched
Capital Projectunmatched
Commissioningunmatched
Construction Engineeringunmatched
Data Qualityunmatched
Documentation Planunmatched
Documentation Standardsunmatched
Drug Productsunmatched
Embedded Systemsunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
Manufacturingunmatched
Manufacturing Operationsunmatched
Manufacturing Systemsunmatched
Manufacturing/Industrial Processesunmatched
Regulationsunmatched
Requirements Managementunmatched
System Operationsunmatched
Systems Administration/Managementunmatched
Test Scriptsunmatched
Writing Skillsunmatched
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