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Commissioning & Qualification Engineer

Job in Columbus, Franklin County, Ohio, 43224, USA
Listing for: Intellectt Inc
Full Time position
Listed on 2026-06-11
Job specializations:
  • Engineering
    Validation Engineer, Pharma Engineer, Quality Engineering, Manufacturing Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
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
.

Key Responsibilities
  • 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
Required Skills
  • 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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