5-7 years of experience in Commissioning & Qualification (C&Q) within a pharmaceutical setting
Strong background in hands-on equipment commissioning and system turnover
Proven expertise in secondary and tertiary packaging operations for pharmaceutical products
Deep understanding of FDA, GMP, and other regulatory standards
Excellent documentation skills related to C&Q and compliance requirements
Responsibilities
Lead commissioning and qualification for new packaging equipment installations
Develop and execute C&Q documentation like plans and protocols
Conduct hands-on equipment verifications on the manufacturing floor
Manage tracking and resolution of punch list items until system acceptance
Collaborate with vendors and internal teams to ensure system compliance and functionality
Support Site Acceptance Testing (SAT) for new equipment
Ensure C&Q activities comply with all regulatory standards
Apply manufacturing process knowledge to inform commissioning criteria
Maintain accurate C&Q records in line with regulatory requirements
Benefits
Opportunities for professional development and training
Collaborative work environment with diverse teams
Ability to contribute to major capital expansion projects
Engagement in advanced pharmaceutical packaging technologies
Hands-on role with tangible impacts on drug product manufacturing operations
Full Job Description
Job Summary:
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.
Roles & 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
Apply 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
Experience:
Experienced Commissioning & Qualification (C&Q) professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a regulated pharmaceutical environment
Experience supporting pharmaceutical secondary and tertiary packaging operations for final drug product
Hands-on experience in equipment commissioning, system turnover, and manufacturing floor execution
Knowledge of FDA, GMP, and applicable site and regulatory standards
