Senior Validation Engineer
Company: Naderi Engineering, Inc.
Location: Vacaville
Posted on: August 2, 2022
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Job Description:
Description:
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 Vacaville 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.Job Responsibilities--- 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.
Job RequirementsEducation:--- Bachelors degree (Life Science,
Engineering)A minimum of 6 years of Validation experience.
Keywords: Naderi Engineering, Inc., Vacaville , Senior Validation Engineer, Engineering , Vacaville, California
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