CSV engineer

Work schedule : 5 days a week on-site / Standard work hours (8 or 9 to 4 or 5)

Client description :

• Cell and Gene therapy company
• Fast growing, well-funded company on the cutting edge of cell and gene tech.

Project description :

Our client is currently building (started in 2024) a 125,000 sq ft greenfield manufacturing facility

outside of Pittsburgh, PA

o Expected to be operational by 2027 Q1

o The electricity gets turned on in this facility in the end of Jan 2026

The facility will be state of the art and will be in partnership with U of Pitt.

It will be focused on Gene Editing, iPSC tech, and cell, vector and protein engineering

capabilities.

Our client is looking to add an Owner's Rep CSV Engineer to help support the project.

Client is implementing several computer systems in the coming months and this person will

support them.

o Blue Mountain Ram is being implemented now.

Manager is working on the Validation Master Plan now.

This resource will support writing the SOPs, make sure the documents from

vendor are correct : meet Part 11, GAMP compliant.

They will also write an addendum to the SOPs, etc. if needed.

o Environmental Monitoring

o Automation System

Being built now.

This resource will work with the overall project team to create and review all validation

documents, write protocols, scripts, and reports. They will also execute validation protocols.

o They will also be responsible for making sure all modifications to the systems are

compliant and good.

Technology environment the consultant will be working in : Blue Mountain, MS, Kneat, Veeva

Consultants day to day responsibilities :

Support the implementation of Computer Systems, to include :

o Supporting the creation of Validation Master Plans

o Writing the SOPs, make sure the documents from vendor are correct : meet Part 11,

GAMP compliant.

o They will also write an addendum to the SOPs, etc. if needed.

Work with the overall project team to create and review all validation documents, write

protocols, scripts, and reports. They will also execute validation protocols.

o They will also be responsible for making sure all modifications to the systems are

compliant.

Required Skills :

Prior experience as an Owner's Rep CSV Engineer on a Greenfield build. Must have experience :

o Cell and Gene exp.

o Working with Blue Mountain Ram, Automation systems and Building Management

systems.

o Working with the overall project team to create and review all validation documents,

write protocols, scripts, and reports.

o Executing validation protocols.

o Ensuring all modifications to the systems are Part 11 and GAMP compliant.

o Supporting the creation of Validation Master Plans

o Writing the SOPs

Ensuring the documents from vendors are correct : meet Part 11, GAMP

compliant.

Writing addendums to the SOPs, etc. if needed.

Desired Skills :

KNEAT

VEEVA