Commissioning & Qualification; C&Q Engineer
Listed on 2026-05-31
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Engineering
Validation Engineer, Quality Engineering, Manufacturing Engineer, Pharma Engineer
Job Title: Commissioning & Qualification (C&Q) Engineer
Employment Type: W2 only
Duration: 6 Months Contract (Possible Extension)
Job DescriptionWe are seeking an experienced Commissioning & Qualification (C&Q) Engineer to support a major capital expansion project involving the installation of four new pharmaceutical packaging lines. This role is embedded within a pharmaceutical secondary and tertiary packaging environment supporting final drug product operations.
This is a hands‑on C&Q execution role, requiring strong expertise in equipment commissioning, system turnover, and manufacturing process understanding within a regulated GMP environment.
This is not a validation-focused role.
The selected candidate will lead commissioning and qualification activities to ensure all systems are installed, tested, verified, and ready for seamless handover to GMP manufacturing operations.
Key Responsibilities- Lead end-to-end commissioning and qualification activities for new secondary and tertiary packaging equipment across four new packaging lines in Building 2
- Develop, author, review, and execute C&Q documentation, including commissioning plans, protocols, test scripts, punch lists, and turnover packages
- Perform hands‑on equipment walkdowns, system verifications, and commissioning checks on the manufacturing floor
- Manage punch list tracking, resolution, and system acceptance through final turnover
- Collaborate with vendors, engineering, construction, and operations teams to ensure equipment is installed and commissioned to design specifications
- Support and execute Site Acceptance Testing (SAT) for incoming packaging equipment
- Ensure all commissioning activities comply with FDA, GMP, and site regulatory standards
- Apply strong manufacturing process knowledge to define commissioning scope and acceptance criteria aligned with real operational needs
- Partner with Quality, Manufacturing, and Engineering teams to ensure smooth and compliant system turnover into GMP operations
- Maintain complete and accurate C&Q documentation in alignment with data integrity and site standards
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