C&Q Engineer

Responsibilities

• 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

• Degree in Science or Engineering, or equivalent.
• 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.

We welcome applications from every walk of life and are committed to diversity within the industries we support.