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Software Validation Engineer

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Master Compliance Inc

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Location:
United States , Irving

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Master Compliance, Inc. in Irving, TX is seeking Software Validation Engineer(s) to design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.

Job Responsibility:

  • Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements
  • Develop validation strategy for manufacturing equipment and lab equipment such as chromatography systems, burst testers, leak testers, freezers, Kaye validators, and building automation systems
  • Closely work with suppliers in qualification of manufacturing and lab equipment according to client policies and procedures
  • Develop User Requirements, System Requirements including system flow diagram Specifications, Configuration and Design Specifications
  • Develop test strategy and test plan for all validation testing activities (OQ, PQ and Pre-validation UAT protocols)
  • Author, review, and execute Validation Plan, Design Review, IQ Protocol/ Report, OQ Protocol/Report, PQ Protocol/Report, test cases, test incidents, trace matrix, change controls and validation report
  • Execute validation test protocols and document the test results
  • Develop defect reports and track them for its resolution and maintain Requirements Traceability Matrix (RTM) and prepare test summary report to summarize all the test activities including any open deviations
  • Provide guidance on business process improvements to follow lean manufacturing methodology
  • Track and monitor review and approval of validation deliverables, participate in meetings with project team and client stakeholders as required
  • Participate in internal or external training programs to maintain knowledge of validation principles

Requirements:

  • Master’s degree in Information Systems Technologies, Computer Science, 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
  • Demonstrable proficiency, skill, experience, and knowledge with Regulatory Compliance: FDA 21 CFR Part 11 and GxP guidelines
  • Demonstrable proficiency, skill, experience, and knowledge with Create and maintain validation documentation, including validation plans, protocols, and reports
  • Demonstrable proficiency, skill, experience, and knowledge with Conduct risk assessments to identify and mitigate potential compliance and system risks
  • Demonstrable proficiency, skill, experience, and knowledge with Good Documentation Practices (GDP) principles for maintaining accurate and organized records
  • Demonstrable proficiency, skill, experience, and knowledge with Software testing methodologies and experience in executing validation tests (IQ, OQ, PQ)
  • Demonstrable proficiency, skill, experience, and knowledge with Change control processes to manage modifications to validated systems
  • Demonstrable proficiency, skill, experience, and knowledge with Validation tools and software for data integrity and system validation
  • Demonstrable proficiency, skill, experience, and knowledge with IT and system architecture to understand and validate computerized systems
  • Demonstrable proficiency, skill, experience, and knowledge with Communication as liaise with cross-functional teams, vendors, and regulatory authorities
  • Demonstrable proficiency, skill, experience, and knowledge with Project management skills to ensure validation projects are completed on time and within budget

Additional Information:

Job Posted:
December 10, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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