Application / Validation Engineer
3 weeks ago
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.
Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE/MBE/SBE/SDB firm accredited by WBENC, NMSDC, and SBA.
Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.
At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.
To learn more about us, please visit our website www.trinus.com
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