Commissioning & Qualification Engineer
Job in
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-06-11
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-06-11
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below
We are hiring an experienced Commissioning & Qualification (C&Q) Engineer to support a major pharmaceutical expansion project involving 4 new packaging lines
. This hands‑on role focuses on equipment commissioning, qualification, system testing, and turnover within a GMP pharmaceutical packaging environment
. This is not a validation role
.
- Lead commissioning and qualification activities for new packaging equipment installations
- Develop and execute C&Q documents, protocols, test scripts, and turnover packages
- Perform equipment inspections, system checks, and commissioning activities on the manufacturing floor
- Track and resolve punch list items until system acceptance and turnover
- Support Site Acceptance Testing (SAT) for new equipment
- Work with engineering, vendors, construction, quality, and operations teams to ensure successful installation and startup
- Ensure compliance with FDA, GMP, and regulatory standards
- Support smooth handover of commissioned systems into GMP manufacturing operations
- Maintain accurate C&Q documentation and records
- Strong experience in Commissioning & Qualification (C&Q) within pharmaceutical manufacturing
- Hands‑on experience with packaging equipment commissioning and system turnover
- Knowledge of GMP, FDA regulations, and pharmaceutical manufacturing processes
- Experience with SAT, equipment qualification, and documentation management
- Strong collaboration and troubleshooting skills
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