Commissioning and Qualification Lead – REF 02021MQ

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.

Upload your CV/resume or any other relevant file. Max. file size: 256 MB.
Check the box to confirm our use of your data under GDPR regulations. To register your CV you must tick the checkbox to confirm your acceptance of our GDPR and Privacy Policy