C&Q Engineer

Katalyst CRO; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Job summary

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

You will lead and execute commissioning and qualification activities across installations, ensuring systems are built, installed, and functionally verified to specification and ready for handover to GMP manufacturing operations.

Qualifications

• Deep expertise in commissioning, qualification, and system turnover for regulated pharma environments.
• Experience supporting packaging operations for final drug product.
• Hands-on experience performing walkthroughs, verifications, and on-floor execution.
• Solid knowledge of FDA, GMP, and site regulatory standards.

Responsibilities

• Lead and execute commissioning and qualification activities for four new packaging lines in Building 2.
• Develop, review, and execute C&Q documentation including plans, protocols, test scripts, punch lists, and turnover packages.
• Perform walkdowns, verifications, and commissioning checks on the manufacturing floor.
• Manage punch lists through to system acceptance and turnover.
• Collaborate with vendors, engineering, construction, and operations to ensure installations meet design specs.
• Support SAT activities for incoming packaging equipment.
• Ensure all C&Q activities comply with FDA, GMP, and site/regulatory standards.
• Apply manufacturing knowledge to ensure acceptance criteria reflect real-world operations.
• Partner with Quality, Manufacturing, and Engineering to ensure clean turnover to GMP operations.
• Maintain accurate C&Q records in line with data integrity requirements.

Skills

C&Q expertise

Equipment commissioning

System turnover

GMP knowledge

Packaging 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.
• 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

Job Summary

• 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