Commissioning & Qualification Engineer

Katalyst CRO; Cincinnati (OH); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst CRO in Cincinnati seeks an experienced Commissioning & Qualification (C&Q) Engineer to support a major capital expansion involving four new packaging lines. This hands-on role sits within a pharmaceutical packaging operation for final drug product.

You will lead C&Q activities, develop and execute documentation, perform floor walkdowns, and ensure systems are built, installed, and verified to specification for GMP turnover.

Qualifications

• Experience in commissioning and qualification activities in a regulated pharma environment.
• Understanding of GMP, FDA requirements and manufacturing processes.
• Ability to perform equipment walkdowns and verify system performance.

Responsibilities

• Lead and execute commissioning and qualification activities for four new packaging lines.
• Develop, author, review, and execute C&Q documentation (plans, protocols, test scripts, punch lists, turnover packages).
• Perform hands-on equipment walkdowns, verifications, and commissioning checks on the manufacturing floor.
• Manage punch list tracking and resolution through to turnover and acceptance.
• Collaborate with vendors, engineering, construction, and operations to ensure installed systems meet design specifications.
• Support Site Acceptance Testing (SAT) for incoming packaging equipment.
• Ensure all C&Q activities comply with FDA, GMP, and site standards.
• Apply manufacturing process knowledge to reflect real-world operational requirements in acceptance criteria.
• Partner with Quality, Manufacturing, and Engineering to enable GMP turnover of commissioned systems.
• Maintain accurate C&Q records in line with data integrity standards.

Skills

Commissioning & Qualification

Manufacturing process knowledge

FDA GMP compliance

Equipment walkdowns

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.

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.