9401 Validation Engineer III
The Validation Engineer III position is responsible for defining qualification/validation strategies and coordinating testing activities required to complete assigned projects in support of the operation of the Commercial Manufacturing Facility.
Performance of such validation activities include Equipment/Utility/Facility Qualification, Cleaning Validation, Steaming/Sanitization/Sterility Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire.
Responsible for performing the Commissioning and Qualification of equipment, utility systems, automation systems, processes, and facilities.
Prepares Validation Protocols, Commissioning Plans, performs testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports.
Support/Represent the Validation department on project teams and contribute directly to the completion of projects by providing validation assessments as a member of the project team.
Participate in meetings with Subject Matter Experts discussing the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
Executes studies for the introduction of new products to the existing manufacturing facility.
This may include the assessment of cleaning validation requirements as part of the New Product Introduction program to ensure our multi-product status is maintained.
Training is maintained to ensure job responsibilities can be performed on a daily basis.
Bachelors degree (Life Science, Engineering).
A minimum of 6 years of Validation experience.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.