Sr. Validation Specialist- Lims focused

Location: Lehigh Valley, PA

Job Description

Sr. Validation Specialist for a  LIMS upgrade and migration project.  

Typical validation/SDLC life cycle deliverables will include, but are not limited to:
  • Validation/Migration Plan
  • System Requirements update
  • Design Configuration Update
  • PQ revision/Execution
  • Final Report

CSV Consultant for LIMS: 
  • Minimum of 5 years experience leading computer system validation efforts
  • Participate in the development, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
  • Preparation, review and issuing of CSV  documents as they related to computer systems
  • Author, execute, perform, summarize CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling, and Supplier Assessments.
  • Experience in developing Server qualification plans, specifications, test protocols, and reports
  • Support change control activities, deviations and SOP’s for computer systems
  • Experience with popular SDLC methodologies and validation alignment with each one of them
  • Strong knowledge on 21 CFR Part 11, 210, 211, 820, Annex 11, GDPR, ISO 13485, GAMP 5  regulations and standards