Commissioning & Qualification; C&Q Engineer
Job in
Florence, Boone County, Kentucky, 41022, USA
Listed on 2026-05-31
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-05-31
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering, Manufacturing Engineer -
Manufacturing / Production
Validation Engineer, Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below
Experienced Commissioning & Qualification (C&Q) Engineer required to support a major pharmaceutical capital expansion project. This is a hands‑on C&Q role focused on equipment commissioning, system turnover, and manufacturing process support within a regulated GMP environment.
Required Qualifications:- Bachelor’s degree in Engineering or related technical field
- Strong experience in Commissioning & Qualification (C&Q) within pharmaceutical manufacturing environments
- Hands‑on experience with equipment commissioning, system turnover, and packaging line qualification
- Experience supporting secondary and tertiary packaging operations
- Knowledge of FDA regulations, GMP compliance, and regulated manufacturing standards
- Experience developing and executing commissioning plans, protocols, test scripts, punch lists, and turnover packages
- Experience performing equipment walkdowns, system verifications, and commissioning checks
- Experience supporting SAT (Site Acceptance Testing) activities
- Lead and execute commissioning and qualification activities for four new packaging line installations
- Develop, review, and execute C&Q documentation including commissioning protocols, plans, and turnover packages
- Perform hands‑on equipment walkdowns, system verifications, and commissioning activities on the manufacturing floor
- Manage punch list tracking, resolution, and system turnover activities
- Collaborate with vendors, engineering, construction, manufacturing, and quality teams to ensure successful equipment installation and commissioning
- Support Site Acceptance Testing (SAT) activities for packaging equipment
- Ensure all commissioning activities comply with FDA, GMP, and site regulatory standards
- Apply manufacturing process knowledge to align commissioning scope with operational requirements
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