Pharmaceutical Lab CSV SME

Boston, MA

Job ID: 130731 Industry: Pharma

 

Pharmaceutical Laboratory CSV SME

Environment:

Our client is a Pharmaceutical company that specializes in viral vector contract development and manufacturing for cell and gene therapy companies. Our client is in need a Computer System Validation SME with laboratory experience.

Job Duties/Responsibilities:

This client recently purchased new equipment for their laboratory that has already been installed. The client is in need of a hands-on Computer Systems Validation SME to validate laboratory software. This person will be responsible for writing and executing protocols and summary reports. This person needs to come for a laboratory background and be familiar with laboratory instruments. This person will be responsible for validating excel spreadsheets as well as a PLA system for their ELISA method. Ideally, they would like this person to have experience with EMPOWER 3 validations; the client has an EMPOWER system that needs to be validated. This person will be responsible for PQs and supplemental OQs.

Required:

Pharmaceuticals

Computer Systems Validation

Laboratory Experience

Hands-on writing/executing protocols

Desired:

Empower

Job Type: Contract 

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