Computer Systems Validation Specialist

1 week 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 and reliability of our computer systems.

Key Responsibilities:

  • Develop and maintain a world-class Quality Management System (QMS) for CSV and Data Integrity, including policies, standards, SOPs, templates, and risk-based approaches.
  • Lead the CSV Centre of Excellence (CoE) and Community of Practice (CoP), fostering a collaborative environment for CSV experts and stakeholders to share knowledge and best practices.
  • Provide technical leadership and guidance to project implementation teams and IT staff on GxP applications, ensuring compliance with regulatory requirements.
  • Design and implement a compliance framework and dashboard to proactively monitor and address compliance gaps.
  • Collaborate with cross-functional teams to develop and implement CSV strategies, ensuring alignment with business objectives.

Requirements:

  • Minimum 10 years of hands-on experience in CSV, with a strong background in software development lifecycle, validation, maintenance, and decommissioning.
  • Proven technical leadership skills, with experience in leading CSV approaches for individual projects and educating IT staff on GxP knowledge and practices.
  • Strong working knowledge of data integrity requirements, controls, execution, evidence, and reporting.
  • Experience in supporting regulatory inspections, such as FDA and EMA inspections.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and stakeholders.

What We Offer:

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


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