Applications Engineer II - Irvine, United States - Compunnel, Inc.

Compunnel, Inc. Irvine, United States

2 weeks ago

Description

Job Description

Job Description

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 equipmentInitiates investigations of problems and deficiencies to ensure an important level of product qualityEstablish 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 required2-4 years experience requiredStrong ability to manage and deal with different cultures and nationalitiesSubstantial understanding and knowledge of enterprise information systems such as ERP, PLM, CRM, QMS, etc (such as JDE, SAP, Pilgrim) preferredExperience with FDA guidelines for Software Quality and Systems Validation is a plusKnowledge 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 documentationImplement 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 ExcelProven expertise in usage of MS Office Suite2+ years of experience with python good to have.

(not required)Ability to adapt to rapidly changing environmentAbility to map, troubleshoot, and optimize interfaces with multiple systemsExperience working in complex, matrixed and global business environmentAbility to develop and maintain business and technical documentationDevelop 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

Company DescriptionCompunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions.

A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based/SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments.

Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia.

As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.

We have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year.

Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US.

We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national/ethnic region, disability, or any other basis.

Company Description

Compunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions.