SOFTWARE VALIDATION ENGINEERS

SOFTWARE VALIDATION ENGINEERS

Job Duties :
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 externalpurity, safety, and quality requirements.

Job responsibilities and duties include:

• 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.

Minimum 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.

Qualified applicants must also have demonstrable proficiency, skill, experience, and knowledge with the following:

1) Regulatory Compliance: FDA 21 CFR Part 11 and GxP guidelines.
2) Create and maintain validation documentation, including validation plans, protocols, and reports.
3) Conduct risk assessments to identify and mitigate potential compliance and system risks.
4) Good Documentation Practices (GDP) principles for maintaining accurate and organized records.
5) Software testing methodologies and experience in executing validation tests (IQ, OQ, PQ).
6) Change control processes to manage modifications to validated systems.
7) Validation tools and software for data integrity and system validation.
8) IT and system architecture to understand and validate computerized systems.
9) Communication as liaise with cross-functional teams, vendors, and regulatory authorities.
10) Project management skills to ensure validation projects are completed on time and within budget.

No Travel. No Telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of each project.

Additional Information:

• Job Site: 9901 Valley Ranch Pkwy E., Ste. 3001, Irving, TX 75063
• Email resume to [email protected]
• EOE/Must be legally authorized to work in the United States without sponsorship