6461 - Senior CQV Engineer / Senior Validation Engineer

Verista, Inc.

North Carolina

On-site

USD 81,000 - 99,000

Full time

14 days+
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Job summary

Verista, Inc. in the United States is seeking a Senior CQV Engineer to support validation activities across life science clients. The role focuses on designing validation plans, performing risk assessments, and ensuring compliance with qualification standards.

You will maintain detailed records, draft and verify documentation, run test scripts, and collaborate with project teams to deliver validated systems and processes. This position emphasizes teamwork and rigorous quality.

Responsibilities

  • Designing validation plans
  • Conducting and documenting impact and risk assessments for equipment, systems, and software
  • Maintaining clear records of qualification, validation, and change control for audits
  • Designing and executing studies to define and verify critical process parameters
  • Authoring, editing, and executing commissioning, qualification, and validation documents for equipment and processes
  • Running test scripts and documenting results

Job description

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:
  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Senior CQV Engineer Responsibilities:
  • Designing validation plans
  • Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
  • Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
  • Designing and executing engineering studies for critical process parameter definition and verification prior to validation
  • Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
  • Running test scripts and documenting results
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