Commissioning & Qualification Lead - Isolated Filling Line - GMP

Job type:
Quanta Consultancy Services
flag_no United Kingdom
Contact person:
Lee Mitchell
project ID:

This project is archived and not active any more.
You will find vacant projects in our project database.
Our biopharmaceutical client has a long term contract requirement for an experienced CQV Lead to work on the commissioning & validation activities of a new isolated filling line.  The line is being designed for flexible multi image processing - vial, syring and cartridge.  You will be required to lead and develop the CQV plans for the project and manage a team of CQV engineers through the execution phase.

Responsibilities will include:

Develop the project CQV plan and strategy to ensure all CQV activities are executed in an efficient and compliant manner. 

Lead a team of CQV engineers with project responsibility for:

•  All equipment CQV activities for the new filling line, isolator and associated process equipment.

• All validation studies specific to filter validation, container closure integrity validation, polymeric contact material qualification, cleaning validation, process simulations and process validation. 

Generate, review and approve execution documentation including risk assessments, protocols and reports. 

-  Maintain schedule adherence by tracking and reporting CQV progress, identifying risks and proactively putting mitigation actions in place.

- Provide leadership to the project team by inputting to key project decisions, issue resolution and priority setting

-Manage the day to day activities of the CQV team to ensure priorities are set and in line with the overall project plan

„  Engage with other key functions (QA, Tech Services, Operations, and Engineering etc.) to proactively drive alignment across CQV strategies and approaches. 


Qualifications :

 Minimum of 10 years’ experience working in a CQV role in a cGMP biopharmaceutical or aseptic filling environment is required. 

  Prior experience leading a CQV team through capital projects and new product transfers 

Knowledge of aseptic processing and liquid filling operations preferred. 

Knowledge/experience of the ASTM E2500 validation model is an advantage 

 Good interpersonal skills are required, as is the ability to communicate well, both verbally and written. Must be able to function effectively in a teamwork environment. 

 GMP  requirements for biopharmaceutical manufacturing and or aseptic processing including aseptic liquid filling.