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C&Q Engineer

Katalyst Healthcares and Lifesciences

New Albany, Ohio • 7d ago

Full-time

Job Details

Skills

C
Embedded Systems
Manufacturing Operations
Test Scripts
Management
Collaboration
Acceptance Testing
Regulatory Compliance
Documentation
Data Integrity
Pharmaceutics
Turnover
Manufacturing
GMP

Summary

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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 4cc209ec6d8b1e3dfbbb4f4f9a9ecc27
Posted 30+ days ago

Fitment

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Job Details

Skills

C
Embedded Systems
Manufacturing Operations
Test Scripts
Management
Collaboration
Acceptance Testing
Regulatory Compliance
Documentation
Data Integrity
Pharmaceutics
Turnover
Manufacturing
GMP

Summary

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

Dice Id: 91116760
Position Id: 4cc209ec6d8b1e3dfbbb4f4f9a9ecc27
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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