Pharmaceutical Quality Engineer

Boston, MA

Industry: Pharmaceutical Job Number: 133687

 

Pharmaceutical Quality Engineers

Environment:

Our client is a contract development and manufacturing organization that specializes in developing and commercializing cell and gene therapies. Our client is currently in the process of supporting 3 major projects; a renovation project, a new facility and a new raw materials laboratory. They are in need of quality support to help get the projects up and running.

Job Duties/Responsibilities:

Our client is currently supporting 3 major projects; they are in the process of building a new facility that will be completed in May 2019 as well as supporting a renovation project at their current facility. The 3rd  project that will require support is the construction/build-out of a new raw materials lab at their warehouse site. Due to the major projects, our client is in need of quality engineers to help support compliance and review quality documents.

On a day to day basis, this person will be responsible for reviewing quality records, reviewing/revising SOPs as well as supporting deviation management. This person will also be responsible for the change control process and must be familiar with design processes. This person must come from a pharmaceutical/biotechnology background. It would be ideal if this person has worked with capital projects in the past or has experience brining a facility on-line.

Required:

Pharmaceutical/Biotechnology

Quality Engineering  

Change Controls

Deviation management, SOPs, quality records

Capital Projects/ New facility experience

Job Type: Contract 

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