C&Q Engineer

Katalyst CRO; New Albany (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO seeks an experienced Commissioning & Qualification (C&Q) Engineer for a major expansion project in New Albany, Ohio. The engineer will lead commissioning and qualification for four new packaging lines within a regulated pharmaceutical environment.

This hands-on role requires expertise in equipment commissioning and deep process knowledge to ensure compliance with all relevant standards. The ideal candidate will execute C&Q activities and maintain accurate documentation throughout the process.

Qualifications

• Experienced in equipment commissioning and system turnover.
• Strong knowledge of FDA and GMP standards.
• Hands-on experience in regulated pharmaceutical environments.

Responsibilities

• Lead and execute commissioning and qualification activities.
• Develop and review C&Q documentation.
• Perform hands-on equipment verification and commissioning checks.
• Collaborate with vendors and teams for equipment functionality.

Job description

Roles & Responsibilities

• 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.
• 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.