Validation Specialist
17011 Red Hill Avenue Irvine, CA 92614 US
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.
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