What are the responsibilities and job description for the Commissioning & Qualification (C&Q) Engineer position at Intellectt Inc?
Job Summary:
Seeking experienced C&Q Engineers to support a major pharmaceutical packaging expansion project involving four new secondary and tertiary packaging lines. This is a hands-on commissioning role focused on equipment installation, system turnover, SAT, and qualification activities within a GMP-regulated environment.
Key Responsibilities:
- Execute commissioning and qualification activities for new packaging equipment
- Develop and execute C&Q documents, protocols, test scripts, and turnover packages
- Perform equipment walkdowns, commissioning checks, and system verifications
- Manage punch lists through system acceptance and turnover
- Support SAT activities and collaborate with vendors, engineering, construction, and operations teams
- Ensure compliance with FDA, GMP, and site standards
- Support smooth handover of systems into GMP manufacturing operations
Requirements:
- Strong experience in pharmaceutical C&Q activities
- Hands-on experience with packaging equipment commissioning and system turnover
- Knowledge of GMP/FDA regulated environments
- Experience with secondary/tertiary packaging lines preferred
- Strong troubleshooting, documentation, and cross-functional coordination skills