Ingénieur Qualification

C&Q Engineer - Filling Line

Travel: site based with trip to equipment supplier floor.

Duration: 2-3 years estimated

Full time working hours

Starting date: ASAP

Freelance or Salarial Portage contract

Site near Strasbourg, France

Role General presentation:

The C&Q engineer (filling line) will be in charge for Commissioning & Qualification execution of Filling line systems.

As first mission, they will develop and write all Commissioning & Qualification protocols for the package that they will be assigned, and they will make sure that all documents are reviewed and approved in time.

In the second time, they will coordinate, execute, and complete Commissioning & Qualification that shall be perform from initial testing during FAT until final Qualification acceptance of concerned package.

Role and 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, Automaton, Quality and End Users during the different project phases.
• Collaborate with Automaton contractors in support of integrated C&Q/CSV approach.
• Provide weekly status updates to C&Q filling line Lead

Hard Skills Requirements:

• BS Engineering (or equivalent experience)
• Minimum 5 years C&Q experience in thew pharmaceutical industry, and if possible, in sterile process
• One significant experience in Qualification of fill and finish equipment
• Good knowledge of GMP'S, regulatory requirements, equipment commissioning and qualification.
• One significant experience in Commissioning & Qualification of Isolators packages
• French + English language is mandatory

• KNEAT knowledge is a plus for the position.