SENIOR VALIDATION ENGINEER

SOFTWARE VALIDATION ENGINEERS

Job Duties :
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 following duties:

Job responsibilities and duties include:

• 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.

Minimum 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.

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

1) Engineering principles and concepts relevant to validation processes
2) Industry regulations and standards (FDA, ISO, or GMP)
3) Validation documentation, including protocols, reports, and test plans
4) Validation testing, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/ Performance Qualification)
5) Analyze and interpret validation data, ensuring compliance with established criteria and specifications
6) Risk assessments related to validation processes and develop mitigation strategies
7) Quality management principles and validation activities to meet quality standards
8) Validation equipment and instrumentation
9) Develop and execute validation protocols for equipment, processes, or systems
10) Communication with cross-functional teams, including report findings, status updates, and address issues.

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
• Salary: $108,722 per year
• Email resume to [email protected]
• EOE/Must be legally authorized to work in the United States without sponsorship