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Computer Systems Validation Specialist

2 months ago

Bloomington, Indiana, United States LS Solutions Full time
Job Overview

LS Solutions is seeking a seasoned Computer Systems Validation Specialist to lead our CSV efforts and drive compliance in our software development lifecycle. As a key member of our team, you will be responsible for ensuring the integrity of our computer systems and data.

Key Responsibilities:

  • Lead CSV approaches for individual projects and provide technical leadership to project implementation teams.
  • Develop and maintain a world-class Quality Management System (QMS) for CSV and Data Integrity, including policies, standards, SOPs, templates, and risk-based approaches.
  • Establish and maintain a Centre of Excellence (CoE) and Community of Practice (CoP) for CSV, educating and supporting team members from the CIO to lab SMEs and manufacturing supervisors.
  • Provide CSV SME leadership and support to IT staff maintaining GxP applications.
  • Develop and build a compliance framework and dashboard to proactively monitor compliance and ensure data integrity.

Requirements:

  • Minimum 10 years of hands-on CSV experience with a strong background in assuring compliant computer systems.
  • Proven technical leadership skills and recent Biopharmaceutical Industry experience.
  • Strong working knowledge of data integrity requirements, controls, execution, evidence, and reporting.
  • Experience with infrastructure qualification and regulatory inspections such as FDA and EMA.
  • Ability to educate and mentor IT staff with minimal GxP knowledge and experience.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation package.