Responsibilities : 

  • Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning documents.
  • Preparation of documents associated with C&Q activities.
  • Preparation and execution of FAT, and SAT protocols
  • Review equipment specifications to ensure FAT, SAT and PIM requirements are included, as appropriate.
  • Preparation and execution of Qualification protocols (IQ,OQ, PQ)
  • 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
  • Nonconformity management 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.
  • Collaborate with Automation contractors in support of integrated C&Q/CSV approach.
  • Provide weekly status updates to C&Q Formulation Lead
  • Review C&Q plans/protocols as related to utilities and HVAC systems.
  • Provided monthly update for the C&Q HVAC/Utilities lead

Candidate requirements :

  • BS Engineering (or equivalent experience)
  • Strong knowledge on clean utilities principally and knowledge of HVAC design
  • Minimum 5 years’ experience on Capex projects in the pharmaceutical (Sterile projects is a plus)
  • One significant experience within brownfield project
  • Good Knowledge of GMP’S, regulatory requirements
  • Good written and verbal communication skills with both technical and non-technical staff (French+English)
  • Demonstrated leadership and people management skills.
  • Ability to communicate clearly in an engaging manner with colleagues of various levels of experience (stakeholder management)
  • Comfortable working in a matrix environment, convincing others and having strong level of adaptability.
  • Strong Analytical and problem-solving skills
  • Ability to work in a fast-paced environment and working with strict timelines and deadlines (time management)
  • Ability to work independently and as part of a team
Job Overview
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