C&Q engineer -CPS_AUT_WASHER

January 29, 2024
Application ends: March 29, 2024

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Job Description

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.
● Design Qualification (DQ) protocol preparation, execution, and follow-up
● Preparation and execution of Qualification protocols (IQ,OQ, PQ)
● 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 Material Preparation Lead


Candidate Requirements:
● BS Engineering (or equivalent experience)
● 5 years working in a pharmaceutical environment and if possible, in a sterile process.
● Minimum 5 years C&Q experience
● One significant experience in Qualification of Autoclave, Washer or Component processor
● 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
(French+English)
● KNEAT knowledge is a plus for the position.