CSV engineer
Kasmo Global
Owner's Rep 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 a 125,000 sq ft greenfield manufacturing facility outside of Pittsburgh, PA. Expected to be operational by 2027 Q1. 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.
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.
- Writing 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
Vacancy posted 5 days ago
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