Pharmaceutical Aseptic Design SME

Witchita, KS

Job ID: 125914 Industry: Pharma

 

Pharmaceutical Aseptic Design SME

Project Description:                                                     

Our client is currently in need of a consultant to come on site and design their aseptic process.  Right now the client is looking for the most efficient way to reduce the number of aseptic connections performed on their filling lines.  This consultant will be coming in, conducting a gap assessment and creating a design plan to most efficiently run the process.

 

Day to Day Responsibilities:

This consultant will be responsible for designing the aseptic process.  Currently the clients filling room operators perform manual, aseptic connections in Grade A filling lines of equipment that was sterilized in autoclaves.  The goal is to minimize the number of aseptic connections by redesigning the equipment assemblies and adopting the use of sterile connectors.  These individuals would work alongside an existing engineer, that would provide hands-on support for actually building prototypes, sourcing materials, tubing, filters, filling equipment for testing, etc. 

It is important that this consultant has experience working with sterile filling, fill finish, autoclave connections.   This person will be authoring a protocol to discuss the clients current state with their aseptic process, detailed product codes, how to move forward and acceptance criteria.

Required Skills:

Aseptic Design

Project management skills

Job Type: Contract 

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