Senior Validation Engineer Jobs

Master Compliance Inc

Location:
United States, Irving

Category:
IT - Administration

Contract Type:
Not provided

Salary:

108722.00 USD / Year

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Job Description:

Master Compliance, Inc. in Irving, TX is seeking Senior Validation Engineer(s) to design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements. Individuals will apply advanced-level knowledge of Electrical/Electronic Engineering theories, principles, and concepts, as well as experience with validation engineering to perform the duties.

Job Responsibility:

Lead the IT Validation activities for cloud based computerized systems and applications
Manage end to end validation documentation validation plan, training plan, issues log, design review, IQ protocol/report, OQ protocol/ report, PQ protocol/ report, test cases, test incidents, trace matrix, change controls and validation report
Author and manage the documents required for the development and validation of client’s cloud-based computerized systems, applications, and software
Follow the client validation procedures and requirements in validating new or modified processes and/or systems
Represent validation team in Business workshops, requirement gathering sessions and develop user requirements, system requirements including system flow diagram specifications, configuration, and design specifications
Manage and Plan for all validation testing activities (OQ, PQ and pre-validation UAT protocols) and lead deviation management activities
Develop test strategy and plan in execution of operational and performance protocols
Implement risk based approach and ensure validation tasks are aligned with healthcare regulations and clients SOPS
Lead change control management , Deviation Management ,APA’s investigation
Gather CSV metrics for reporting purposes

Requirements:

Master’s degree in Electrical/Electronic Engineering, Energy Management, or any related field of study and 1-year of experience in the job offered or in any related position(s) in which the required experience was gained
Engineering principles and concepts relevant to validation processes
Industry regulations and standards (FDA, ISO, or GMP)
Validation documentation, including protocols, reports, and test plans
Validation testing, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/ Performance Qualification)
Analyze and interpret validation data, ensuring compliance with established criteria and specifications
Risk assessments related to validation processes and develop mitigation strategies
Quality management principles and validation activities to meet quality standards
Validation equipment and instrumentation
Develop and execute validation protocols for equipment, processes, or systems
Communication with cross-functional teams, including report findings, status updates, and address issues

Additional Information:

Job Posted:
December 10, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Senior Validation Engineer