Pharma C&Q Engineer – Packaging Lines Lead

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

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.