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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