Acceptance Testing, Biotech and Pharmaceutical, C Programming Language, Commissioning, Construction Engineering, Documentation, Documentation Standards, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Problem Solving Skills, Sales Qualification, Test Scripts
Hello,
I hope you're doing well.
My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Commissioning & Qualification (C&Q) Engineer based in Ohiowith one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com
Role: Commissioning & Qualification (C&Q) Engineer
Location: Ohio
Summary:
We are seeking an experienced C&Q Engineer to support a major pharmaceutical packaging expansion project involving four new secondary and tertiary packaging lines. This hands-on role focuses on equipment commissioning, system turnover, and qualification within a GMP-regulated manufacturing environment.
Key Responsibilities
- Lead commissioning and qualification activities for new packaging equipment installations
- Develop and execute C&Q documentation, protocols, test scripts, punch lists, and turnover packages
- Perform equipment walkdowns, system verifications, and commissioning checks on the manufacturing floor
- Support SAT (Site Acceptance Testing) and ensure systems meet design and GMP requirements
- Coordinate with vendors, engineering, construction, quality, and operations teams
- Track and resolve punch list items through final system acceptance and turnover
- Ensure compliance with FDA, GMP, and site documentation standards
Required Skills & Experience
- Strong experience in pharmaceutical Commissioning & Qualification (C&Q)
- Hands-on experience with secondary and tertiary packaging equipment
- Knowledge of GMP, FDA regulations, and manufacturing processes
- Experience with system turnover, SAT execution, and equipment commissioning
- Excellent collaboration and problem-solving skills
Thanks & Regards,
Vyshnavi
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225