Commissioning & Qualification Engineer

Katalyst CRO; Cincinnati (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO in Cincinnati is seeking an experienced Commissioning & Qualification (C&Q) Engineer to support a major capital expansion project with the installation of new packaging lines. The role focuses on executing commissioning activities for packaging equipment and ensuring compliance with FDA and GMP standards.

The ideal candidate will have deep expertise in equipment commissioning and a solid understanding of pharmaceutical manufacturing processes. This position offers a hands-on opportunity to contribute to crucial system turnover activities.

Qualifications

• Deep expertise in equipment commissioning within a regulated pharmaceutical environment.
• Experience in leading commissioning and qualification activities.

Responsibilities

• Lead and execute commissioning and qualification activities for new packaging equipment installations.
• Develop and review C&Q documentation including commissioning plans and test scripts.
• Perform hands-on equipment walkdowns and system verifications.
• Collaborate with vendors and teams to ensure systems meet design specifications.

Skills

Expertise in equipment commissioning

System turnover knowledge

Manufacturing process knowledge

Regulatory compliance (FDA, GMP)

Job description

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 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.

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.