Assistant Professor Department of Electronics Engineering and Communications Technology

Description:

Commissioning and Qualification Lead Fill Finish Facility.

Commissioning and Qualification (C&Q) lead for a portfolio of Capital Projects in the Pharmaceutical Industry. Lead a team of C&Q engineers to ensure the C&Q activities associated with a portfolio of capital projects 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)

Requirements

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