5-7 years of experience in commissioning and qualification within the pharmaceutical industry
Deep expertise in equipment commissioning and system turnover
Hands-on experience in regulated pharmaceutical environments
Strong understanding of manufacturing processes related to secondary and tertiary packaging
Familiarity with FDA and GMP compliance standards
Responsibilities
Lead commissioning and qualification for new packaging equipment installations
Develop and execute C&Q documentation including plans and protocols
Perform hands-on checks and verifications on the manufacturing floor
Manage and resolve punch lists through system acceptance
Collaborate with multifunctional teams including vendors and engineering
Support Site Acceptance Testing for new equipment
Ensure compliance with FDA and GMP during C&Q activities
Apply operational knowledge to set realistic acceptance criteria
Maintain C&Q records in line with site standards
Benefits
Opportunity to work on a major capital expansion project
Engage in hands-on activities directly impacting operational success
Join a team specializing in cutting-edge pharmaceutical packaging
Make a significant impact on the operational transition to GMP compliance
Collaboration with diverse teams enhances professional network
Full Job Description
Job Description:
We are looking for an experienced Commissioning & Qualification (C&Q) Engineer to join our team in support of a major capital expansion project involving the installation of four new packaging lines.
This is a hands-on C&Q role embedded within a pharmaceutical secondary and tertiary packaging operation for final drug product.
This is not a validation role, we are looking for a true C&Q professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a regulated pharmaceutical environment.
You will be responsible for leading and executing commissioning and qualification activities across new packaging equipment installations, ensuring all systems are built, installed, and functionally verified to specification and ready for handover to GMP manufacturing operations.
Responsibilities:
Lead and execute commissioning and qualification activities for new secondary and tertiary packaging equipment installations across four new packaging lines in Building 2
Develop, author, review, and execute C&Q documentation including commissioning plans, commissioning protocols, test scripts, punch lists, and turnover packages
Perform hands-on equipment walkdowns, system verifications, and commissioning checks directly on the manufacturing floor
Manage punch list identification, tracking, and resolution through to system acceptance and turnover
Collaborate with equipment vendors, engineering, construction, and operations teams to ensure systems are installed, functional, and commissioned to design specification
Support and execute SAT (Site Acceptance Testing) activities for incoming packaging equipment
Ensure all C&Q activities are performed in compliance with FDA, GMP, and applicable site and regulatory standards
pply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect real-world operational requirements
Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of commissioned systems into GMP operations
Maintain accurate and complete C&Q records in compliance with site documentation standards and data integrity requirements.
