C&Q engineer – Filling Line_Unloading Robotic

January 29, 2024
Application ends: March 29, 2024

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Job Description

 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 filling line Lead

Candidate 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 Robotic equipment within Pharmaceutical context
 Good knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
 One significant experience in Commissioning & Qualification of Isolators packages
 Good written and verbal communication skills with both technical and non-technical staff
 KNEAT knowledge is a plus for the position.