- 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.
- A degree in science or engineering or equivalent.
- A certificate/diploma in similar areas with appropriate industrial experience
- 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: Black & Clean Utilities, Purification Equipment, Reactors, Filtration equipment, CIP, Upstream process, Downstream process etc.
- Experience with Regulatory and industry standards for GMP and GEP
- Self starter & good team player
- Good oral & written communication skills
What is in it for you?
- Competitive hourly rates
- Stable contract duration