| CSV Engineer :: Pittsburgh, PA Onsite at Pittsburgh, Pennsylvania, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2589138&uid=4abac1400ac94d769ef340048fb80697 From: Praveen Nagar, Vyze inc [email protected] Reply to: [email protected] Job Description - CSV Engineer Location: 5 days a week on-site Pittsburgh, PA Visa: // / Only Duration: 6 months Mode of Interview: Skype Need Linkedin and Local Candidates Only for this role Please submit candidates with resume, license, visa copy as well as rate and Manager references 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 Expected to be operational by 2027 Q1 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 Owners Rep CSV Engineer to help support the project. 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 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. Consultants day to day responsibilities: They will also be responsible for making sure all modifications to the systems are compliant Required Skills: Prior experience as an Owners 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 Keywords: information technology card microsoft Pennsylvania CSV Engineer :: Pittsburgh, PA Onsite [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2589138&uid=4abac1400ac94d769ef340048fb80697 |
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| 09:28 PM 14-Jul-25 |