Applications Engineer II

2 weeks ago

Irvine, United States JobRialto Full time
Job Description:

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, CTE's, 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.

Education: Bachelors Degree

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