Computer Systems Validation Lead

4 weeks ago


Beverly, Massachusetts, United States Carrier Full time
About this role

As a Computer Systems Validation Lead at Carrier, you will be responsible for leading and managing the Validation Program for Sensitech systems and products. This involves working with the Sales, Product, Engineering, and Professional Services teams to develop and execute validation projects that meet regulatory compliance, industry best practices, and business expectations.

Key Responsibilities:
  • Develop and maintain a global Computer System Validation (CSV) methodology and policies/procedures in accordance with current regulatory guidelines.
  • Participate in sales and program design phase to identify customer validation requirements.
  • Lead and manage all validation projects and activities for the development and release of products, in accordance with CSV and regulatory requirements.
  • Oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and user acceptance testing (UAT).
  • Maintain and update validation documentation, ensuring its accuracy and completeness.
  • Evaluate proposed changes to validated systems and recommend level of validation support required.
  • Lead internal audits of CSV activities, protocols and procedures.
  • Identify, document, and track non-conformances and corrective/preventative actions related to validation activities.
  • Pursue continuous improvement opportunities to ensure effectiveness of the validation program.
  • Stay current on the latest GxP regulations and industry best practices for Computer System Validation.
  • Conduct risk assessments to identify potential validation gaps. Propose and execute on mitigation strategies.
  • Provide appropriate training and guidance to employees and partners on CSV procedures and policies.
  • Identify, track, and provide response plans for key performance indicators.
Basic Qualifications
  • HS Diploma with 5 years of Computer System Validation experience
  • 5+ years of experience managing cross functional projects
  • Up to 5% travel required
Preferred Qualifications
  • Bachelor's Degree in Quality or Engineering
  • Experience with Medical Device Product Validation a Plus
  • Experience and knowledge of ISO 9001 and ISO 17025 requirements
  • Knowledge in the application of 21 CFR Part 11 and Annex 11
  • Knowledge of GxP regulations and their application to CSV
  • Exceptionally strong written and verbal communication skills
  • Ability to manage and prioritize multiple projects
  • Experience with validation methodologies and tools
  • Results driven with a strong customer and quality focus
  • Ability to provide guidance and to execute in the development of validation documents and protocols
  • Demonstrated ability to develop strong relationships and work with staff, colleagues, cross-functional teams, and third parties


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