C&Q Engineer

Title: Commissioning & Qualification (C&Q) Engineer
Location: Ohio
Duration: 6 months
Shift: 1st shift (7:00am 4:00pm)   2nd shift (3:00pm 11:00pm)

Job Description :
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 rolewe 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.

Key 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.

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Contract