Aseptic Process Engineering

Witchita, KS

Job ID: 126274 Industry: Pharma


Aseptic Process Engineer

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 building prototypes, sourcing materials, tubing, filters, filling equipment for testing, etc. 

The consultant needs to be familiar with process engineering in an ISO 5/Grade A environment.  There will also be responsibility for owning and completing change controls and CAPA’ s.  The system that this consultant should be familiar with is Trackwise.

Required Skills:

Aseptic Process Engineering

CAPA’ s/Change controls

Project management skills

Job Type: Contract 

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