CSV Engineer at Pittsburgh, PA (Onsite)

Title : CSV Engineer

Location :Pittsburgh, PA (Onsite)

Job Type : 12+ Months Contract

Interview Mode: Video

Project description:

• Our client is currently building (started in 2024) a 125,000 sq ft greenfield manufacturing facility outside of Pittsburgh, PA
  • Expected to be operational by 2027 Q1
  • The electricity gets turned on in this facility in the end of Jan 2026
• 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.
  • 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.
  • Environmental Monitoring
  • 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.
  • 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:
  • Supporting the creation of Validation Master Plans
  • 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.
• Work with the overall project team to create and review all validation documents, write protocols, scripts, and reports. They will also execute validation protocols.
  • 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:
  • Cell and Gene exp.
  • Working with Blue Mountain Ram, Automation systems and Building Management systems.
  • Working with the overall project team to create and review all validation documents, write protocols, scripts, and reports.
  • Executing validation protocols.
  • Ensuring all modifications to the systems are Part 11 and GAMP compliant.
  • Supporting the creation of Validation Master Plans
  • 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