• Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning
• 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
Hard Skills Requirements:
• BS Engineering (or equivalent experience)
• 5 years working in pharmaceutical environment and if possible, in sterile process.
• Minimum 5 years C&Q experience
• One significant experience in Qualification of formulation package or equivalent equipment
• Good knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
• Good writen and verbal communication skills with both technical and non-technical staff (French+English)
• KNEAT knowledge is a plus for the position.

Candidate requirements :
• Demonstrated leadership and people management skills.
• Ability to communicate clearly in an engaging manner with colleagues of various levels of experience.
• Comfortable working in a matrix environment, convincing others.
• Strong Analytical and problem-solving skills
• Ability to work in a fast-paced environment.
• Ability to work independently and as part of a team

Job Overview
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