Software Validation Engineer
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Opelika, AL 36803
Req Ref No: SGALTE774
Location: Opelika , AL
Duration: 6.0 months
This position is accountable for leading and performing activities in support of the validation and compliance of a computerized system to ensure system meets its’s intended use.
The Software Validation Engineer will work with a Manufacturing, Engineering and IT team(s) to validate Systems that are compliant to applicable regulations (21 CFR Part 11, GxP Regulations) and client Quality Management System.
Essential Duties and Responsibilities:
1. Prepares documentation in client’s document management system per policy and procedure to support the validation of Systems supporting Manufacturing Plant.
2. Identify and escalate, as necessary project risks and issues to the Project Manager and/or Site Leadership.
3. Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system.
a. Create/Review validation documents in the project following Software Development Life Cycle (SDLC).
i. Working with Business partners, create/reviews User Requirements, Functional Specifications, Design Specifications and Configuration Specifications.
ii. Authors Validation Plan, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Risk Management Report, Test Incidents, Trace Matrix, System Description, and Validation Report.
iii. Routes validation documents for electronic approval within the document management system or the electronic testing tool.
4. Protocol/Test Execution
a. Outlines testing based on the Risk Management strategy.
b. Manages and executes validation testing plans and test cases – executes the overall protocol process, including test case creation/approval/execution/reviews, test case tracing to the system requirements, test incident management, and status reporting.
c. Maintains trace of the system requirements to the test cases per client QMS.
5. System Support and Maintenance
a. Drives System Inventory Management, Change Control, Problem Investigation, and Periodic Review activities.
b. Creates/Reviews System Management Procedures and Manuals to ensure Systems are maintained in validated state.
c. Provides internal/external audit support for Computerized Systems.
Desired skills / Certifications / Training:
1. Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
2. Thorough knowledge of GxP regulations (e.g. 21 CFR Part 11, etc.), Standards, and Industry Best Practices.
3. Experience in Software Development Life Cycle (SDLC) or Software Validation within the Medical Device or Pharmaceutical industry.
4. Strong knowledge of project development/implementation processes.
5. Excellent analytical and judgment capabilities and communication skills, and the ability to work with Cross-Functional Teams.
6. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
7. Proficient in use of Microsoft Office Applications
8. Experience in HP ALM a plus to manage requirement and testing
BS Degree in Engineering, Science or related field
3 years of experience in the Medical device or Pharmaceutical industry
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.