Validation Engineer

Typical CQV Engineer Responsibilities (Level
3)

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

Adherence with project schedule for all assigned activities

Maintaining clear, detailed records qualification and validation

Documenting impact and risk assessments as part of a team

Completing user interface testing, software verification, and complete alarm testing on automated systems

Developing, reviewing, and executing testing documentation

Making recommendations for design or process modification based on test results when executing test scripts

General understanding of capital equipment implementation and process knowledge

Understanding validation documents, URS, IQ, OQ, PQ

Independently understanding client's quality standards, cGMP's, and regulatory standards to support team in compliance of validation effort

Independent verification of testing against specifications

Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities
- Includes ability to complete root cause analysis

Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release

Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer