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Validation Specialist

Irvine, CA 92614

Posted: 05/15/2024 Employment Type: Contract Job Category: Engineering Job Number: 606873 Is job remote?: No Country: United States

Job Description


Target PR Range: 52-62/hr
*Depending on experience

Summary:

The Validation Specialist will be responsible for ensuring that system, processes, equipment, and products meet quality and regulatory standards. This role involves testing, verifying and validating various aspects of a product or system to ensure that it perform as intended and comply with industry standard and regulation.

Job Responsibilities:
  • Responsible for performing and overseeing the validation of processes, facility, equipment, system, and data cleaning processes.
  • Develop and coordinate execution of protocols for equipment and process validations, prepare final reports following the execution.
  • Assist in the implementation and maintenance of the Validation Master Plan.
  • Configures and tests systems to execute features, integration, and reporting.
  • Design and develop test strategy and methodology for the validation of the products, processes, and equipment
  • Initiates investigations of problems and deficiencies to ensure an important level of product quality
  • Establish the metrics and monitor the performance of processes, equipment, and tools to verify their efficiency, initiate re-validations and process improvement as needed

Qualifications:
  • Bachelor's degree in a technical field such as computer science, computer engineering or related field required
  • 2-4 years experience required
  • Strong ability to manage and deal with different cultures and nationalities
  • Substantial understanding and knowledge of enterprise information systems such as ERP, PLM, CRM, QMS, etc (such as JDE, SAP, Pilgrim) preferred
  • Experience with FDA guidelines for Software Quality and Systems Validation is a plus
  • Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).Experience in authoring/reviewing/approving validation documentation
  • Implement and maintain software development lifecycle (SDLC) processes.
  • 3+ years of SQL experience, should be able to write complex queries including, stored procedure, creating indexes, CTEs, Functions, and query optimization.
  • 2+ years of Power BI experience using and exporting the data.
  • Highly Proficient with Microsoft Excel
  • Proven expertise in usage of MS Office Suite
  • 2+ years of experience with python good to have. (not required)
  • Ability to adapt to rapidly changing environment
  • Ability to map, troubleshoot, and optimize interfaces with multiple systems
  • Experience working in complex, matrixed and global business environment
  • Ability to develop and maintain business and technical documentation
  • Develop and execute software test plans, test scenarios, and test cases.
  • Monitor quality assurance standards and ensure that products meet customer and industry requirements.
  • Identify, analyze, and document software defects.
  • Work closely with other engineers and stakeholders to identify areas for improvement.
  • Develop and utilize test automation tools and techniques.
*CO/NYC candidates might not be considered
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