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Commissioning & Qualification Engineer

Cincinnati, OH, US • Posted 30+ days ago • Updated 12 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

C
Embedded Systems
Pharmaceutics
Manufacturing Operations
Test Scripts
Management
Collaboration
Acceptance Testing
Manufacturing
Turnover
GMP
Regulatory Compliance
Documentation
Data Integrity

Summary

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
pply 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: f170d1f01d6331006257d4ba582dbc5a
Posted 30+ days ago

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