Senior Validation Engineer at LS Solutions in Rensselaer, New York

Posted in Other 2 days ago.

Type: full-time





Job Description:

Job Title: Sr. CSV Lead

Location: Rensselaer, NY

Duration: 12+ months contract

JOB DESCRIPTION
  • Responsible for managing end-to-end CSV deliverables for both new & existing applications.
  • Responsible for Implementation of Lab, Enterprise and Manufacturing systems and supporting change management of existing systems.
  • Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team.
  • Support Engagement Lead with resource interviews, allocation, utilization, schedule forecasting & adjustments as required.
  • Author the following CSV Deliverables: Initial System Assessment, Functional Specifications, Functional Risk Assessment, Design Documents, SOP Planning, Data Integrity Assessment, Traceability Matrix, protocols (IQ, OQ, PQ), Interim Memo & Validation Summary Report
  • QA Review of the following CSV Deliverables: User Requirements, SOPs Application Administrative Tasks & Protocol Deviation

Required Skillset

The must haves!
  • Management (fte and / or contractors)
  • Project Management experience
  • Need to have strong experience in CSV ERP, Lab Systems, Automation, and Manufacturing

Personality:
  • Strong Communication skills, internally and externally to our clients' clients
  • Go getter / someone who takes initiative / someone who is proactive

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