Job Description

Commissioning and Qualification Lead

Headcount Solutions is seeking a Commissioning and Qualification (C&Q) lead for a large-scale Fill Finish Project in the Pharmaceutical Industry. This person will lead a team of C&Q engineers to ensure the C&Q activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Key Responsibilities:

* Coordinate and Supervise all C&Q activities.

* Approve C&Q planning documents detailing overall strategy for the project.

* Develop and approve the master list of C&Q test documents and activities.

* Review and approve all C&Q summary reports.

* Ensure the C&Q schedule is developed and maintained.

* Ensure all C&Q Engineers who perform C&Q activities have relevant training assigned.

* Pre-approval and post-approval of C&Q test documents.

* Manage daily C&Q coordination meetings.

* Responsible for overall tracking and reporting of C&Q status and risks/issues.

* Ensure start-up of equipment/utilities is completed in a safe and coordinated manner.

* Assist in the development of User Requirement Specifications (URS’s) and Quality Risk

Assessment for Equipment and Automated Systems (QRAES)


* 6+ years’ experience in Engineering or Commissioning and Qualification Management

* Technical qualification at third level or equivalent in Engineering.

* Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.

* Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.

* Knowledge of safety, GMP and environmental regulatory requirements.

* Demonstrated strong communication and leadership skills.

* Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.

* Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.

For further information please contact Mick on (phone number removed) or forward details in confidence to