Lead SDMS Computer System Validation Specialist

Location: Cambridge, MA
Date Posted: 05-02-2018
Title: Lead SDMS Computer System Validation Specialist

Type of role: Contract / Duration: 12+ months

Location: Cambridge, MA 02142
Primary Responsibilities:
  • Lead validation activities directly associated with the upgrade of client’s Waters NuGenesis SDMS. 
    • This includes: understanding the business, determining business and system requirements, project planning for validation work-stream, and collaborating with project team members in the development and delivery of validation deliverables.
  • Provide strong validation direction to internal and external project team members.
  • Author validation deliverables including Validation Plan, User Requirements Specification, Configuration Specification, Design Specification, IQ, Requirements Test Plan and Scripts, Traceability Matrix and Validation Summary Report for assigned projects.
  • Oversee team contributions to deliverables, testing activities and ensure validation testing is conducted in an appropriate and timely manner.
  • Work collaboratively across functions with Quality Management, IT, Business, Vendors and Consultants to plan, coordinate and execute computer system validation activities.
Knowledge and Skill Requirements:
  • Minimum 10 years of validation experience.
  • Previous experienced in validating Laboratory Information Systems – particularly Waters NuGenesis SDMS.
  • Strong experience in leading and performing validation activities.
  • Ability to manage internal and external resources to deliver required validation package and execution.
  • Excellent problem solving skills
  • Ability to work independently as a Senior Validation, provide guidance to project team on validation approach and communicate risks or issues to management.
  • Strong foundational understanding and experience leading validation workstream.
  • Strong knowledge of 21 CFR Part 11, Annex 11 and cGMPS
  • Excellent verbal and written skills
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