Acceptance Testing, Biotech and Pharmaceutical, C Programming Language, Commissioning, Communication Skills, Construction Engineering, Cross-Functional, Data Quality, Documentation, Documentation Plan, Drug Manufacturing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Manufacturing, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Problem Solving Skills, Project Execution, System Operations, Team Player, Technical Writing, Test Scripts
Columbus, OH
Project Duration: 6 9+ MonthsJob Summary:
We are looking for an experienced Commissioning & Qualification (C&Q) Engineer to support a major pharmaceutical packaging expansion project involving the installation of four new packaging lines. This is a hands-on role focused on commissioning, system turnover, and qualification activities within a GMP-regulated pharmaceutical manufacturing environment. The ideal candidate will have strong experience with packaging equipment commissioning, system verification, SAT execution, and equipment turnover within pharmaceutical manufacturing operations.
Key Responsibilities:- Lead and execute commissioning and qualification activities for new secondary and tertiary packaging lines
- Develop, review, and execute C&Q documentation including commissioning plans, protocols, test scripts, punch lists, and turnover packages
- Perform equipment walkdowns, system verifications, and commissioning activities on the manufacturing floor
- Manage punch list tracking, issue resolution, and system turnover activities
- Support Site Acceptance Testing (SAT) for new packaging equipment installations
- Collaborate with vendors, engineering, construction, manufacturing, and quality teams to ensure successful equipment installation and commissioning
- Ensure all commissioning activities comply with FDA, GMP, and company standards
- Apply manufacturing process knowledge to verify systems meet operational and production requirements
- Support clean handover of commissioned systems into GMP manufacturing operations
- Maintain accurate documentation and data integrity throughout project execution
Preferred Qualifications- Strong experience in Commissioning & Qualification (C&Q) within pharmaceutical manufacturing
- Experience supporting packaging equipment and packaging line installations
- Knowledge of GMP and FDA-regulated environments
- Hands-on commissioning, equipment verification, and turnover experience
- Experience with secondary and tertiary packaging systems
- Strong technical documentation and protocol execution skills
- Excellent communication and cross-functional collaboration abilities