CQV Engineer Senior
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Job Description
Job Title: CQV Engineer (Senior)
Overview:
Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely as per schedule and in compliance with GMP and Quality Requirements.
Requirements
Key Responsibilities:
Coordinates and Supervises all C&Q activities on their assigned projects.
Generate C&Q planning documents detailing overall project strategy.
Develops the master list of project C&Q test documents and activities.
Generates all C&Q summary reports.
Ensures the C&Q schedule is developed and maintained.
Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report)
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 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.
Key Responsibilities: Coordinates and Supervises all C&Q activities on their assigned projects. Generate C&Q planning documents detailing overall project strategy. Develops the master list of project C&Q test documents and activities. Generates all C&Q summary reports. Ensures the C&Q schedule is developed and maintained. Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report) 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 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.
Employment Type
Full Time
