About the role IT Acceleration provides managed IT, compliance and computer system validation services to life sciences companies. We are looking for an experienced CSV consultant to author and execute validation packages for our clients on a project basis. This is hands-on validation work. You will be writing the documents and running the scripts, not overseeing someone else who does. Our clients operate under GLP and their systems hold regulated study data, so the work has to stand up to a Quality Assurance review and, ultimately, to an inspection. Engagements are scoped by project. Volume varies with our clients' validation pipelines, so this suits someone who wants steady contract work alongside other commitments rather than a single full-time position. What you will do

• Author validation deliverables: system impact assessments, validation plans, risk assessments, requirements and functional specifications, traceability matrices, and 21 CFR Part 11 assessments.
• Write, dry run and execute IQ, OQ and PQ protocols and test scripts, and support client subject matter experts through formal execution.
• Draft and disposition test discrepancies and deviations, and author validation summary reports.
• Evaluate vendor-supplied validation evidence and build the case for leveraging it, rather than repeating work a supplier has already done and documented.
• Carry out supplier assessments and Part 11 vendor evaluations.
• Work inside the client's quality management system, route documents through their QA review cycles, and respond to review comments.
• Keep validation packages current through change control and periodic review. What you will bring
• Demonstrable experience authoring and executing complete validation packages in a GxP-regulated environment. We will ask you to walk us through packages you have personally written.
• Working knowledge of GAMP 5 (2nd Edition), 21 CFR Part 11, and EU Annex 11. Familiarity with 21 CFR Part 58 and GLP data integrity expectations is important, since much of our work sits there.
• Experience validating both laboratory instrument systems and enterprise platforms such as LIMS, electronic document management and preclinical study data systems.
• Comfort with computer software assurance and risk-based approaches, and the judgment to argue for a proportionate scope rather than validating everything to the same depth.
• The writing ability to produce controlled documents that pass QA review without extensive rework.
• Self-direction. You will often be the only validation resource on a project, working to a plan and a date. Useful, not required
• Experience with a digital validation platform such as Valkit, ValGenesis or Kneat. Our current work is Valkit-based and we will train you on it.
• Veeva Vault, or another controlled document management system used for approvals and workflows.
• Preclinical or contract research organization experience, particularly with in-life study data, environmental monitoring, or analytical instrumentation.
• Experience being the validation representative in a regulatory inspection or client audit.

How the engagement works You will contract with IT Acceleration, not with our clients. We hold the client relationship, set the scope and manage the project. You are responsible for the deliverables and for meeting the dates in the plan. Work is assigned by project with an estimated hour allocation agreed in advance. Hours beyond that allocation are approved in writing before they are worked, so you are never asked to absorb scope. Most of the work is remote. Some execution activity has to happen on site, typically in the greater Philadelphia area, and is scheduled with notice. Rate $90-120 per hour, invoiced monthly against hours logged, payment net 15 from invoice date. To apply Send a resume together with a short note describing two validation packages you authored, what the systems were, what you personally produced, and how the scope was justified. We are more interested in that than in a cover letter.

Pay:

$90.00 - $120.00 per hour

Work Location:

Hybrid remote in King of Prussia, PA 19406