Website Asset Recruitment
Our client is a bulk pharmaceutical manufacturing facility which develops and supplies API and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. They are now looking to hire CQV Engineers (all levels).
The C&Q Engineer shall be responsible for carrying out the following project related activities:
• Preparation of documents associated with lifecycle of C&Q activities for a IV, FT, IQ, OQ.
• Preparation and execution of FAT, Commissioning and SAT protocols
• Preparation and execution of Qualification protocols (IQ and OQ)
• Design Review (DR) and Design Qualification (DQ) protocol preparation, execution and follow-up
• Field Walkdowns of systems as part of transfer of ownership of the system from Construction
• Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
• Installation Verification execution
• System Startup activities
• Functional Testing of systems
• Change Management activities during project lifecycle
• Summary Report writing
• Organize and review daily tasks/verifications and track the progress of the activities assigned
• Contractors and/or Vendors coordination
• Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End Users during the different project phases.
Key Competencies: (Education, Training, Skills, Experience)
• A degree in science or engineering or equivalent.
• A certificate/diploma in similar areas with appropriate industrial experience
• Minimum of 5 years experience of C&Q activities in a large project environment within the pharmaceutical or biotech industries.
• Hands on expertise required in one or more of the following areas: API Facilities, Isolators
• Experience with Regulatory and industry standards for GMP and GEP
• Self starter & good team player
• Good oral & written communication skills