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CQV Engineer

Peter Paul Galligan
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Job Reference: JO-2102-65614_1613733764


CQV Engineering Lead

12 Contract


Commissioning and Qualification (C&Q) lead for a large scale Fill Finish Project in the Pharmaceutical Industry. The successful candidate 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:

* Coordinates and Supervises all C&Q activities

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

* Develops and approves the master list of C&Q test documents and activities.

* Reviews and Approves all C&Q summary reports.

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

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

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

* Manages Daily C&Q coordination meetings.

* Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.

* Ensures Startup 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)

Education / Experience:

* 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

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Peter Paul Galligan
Peter Paul Galligan
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