C&Q Engineer

Responsibilities

The C&Q Engineer is responsible for the execution of project-related commissioning and qualification activities, including but not limited to the following:

• Preparation of lifecycle documentation in support of C&Q activities, including IV, FT, IQ, and OQ.
• Preparation and execution of Factory Acceptance Testing (FAT), Commissioning, and Site Acceptance Testing (SAT) protocols.
• Preparation, execution, and completion of qualification protocols (IQ and OQ).
• Preparation, execution, and follow-up of Design Review (DR) and Design Qualification (DQ) activities.
• Conducting system field walkdowns as part of the transfer of ownership from Construction to Operations.
• Ensuring safe operation of systems prior to and during start-up, functional testing, and qualification phases.
• Execution of Installation Verification activities.
• Support and execution of system start-up activities.
• Functional testing of systems in accordance with approved protocols.
• Participation in change management activities throughout the project lifecycle.
• Preparation of summary reports and final documentation packages.
• Planning, organising, and reviewing daily tasks and verifications, and tracking progress of assigned activities.
• Coordination with contractors and vendors.
• Interfacing with project stakeholders including Construction, Engineering, Automation, Quality, and End Users across all project phases.

Key Competencies (Education, Training, Skills & Experience)

• Degree in Science or Engineering, or equivalent.

OR

• Certificate or diploma in a related discipline with relevant industrial experience.
• Minimum of 5 years’ experience performing C&Q activities on large-scale pharmaceutical or biotech projects.

Hands-on experience in one or more of the following areas:

• Black and Clean Utilities
• Purification Equipment
• Reactors
• Filtration Equipment
• CIP Systems

• Upstream and/or Downstream Process Equipment
• Strong understanding of GMP and GEP regulatory and industry standards.
• Self-motivated with the ability to work independently and as part of a team.
• Strong oral and written communication skills.