Description

Join a team dedicated to a Mission!

Leidos has an opening for a FDA Test and Validation Analyst located at Fort Detrick, MD, working with the Enterprise Information Technology Project Management Office (eIT PMO). The eIT PMO supports medical research IT solutions to the United States Army Medical Research and Materiel Command (USAMRDC) with the mission to facilitate full coordination, planning, management, and execution of the project to ensure successful acquisition and sustainment of the required IT solution. The eIT PMO’s vision is to be the premier DoD provider of medical research enterprise IT solutions.

If this sounds like the kind of environment you can thrive, keep reading!

The FDA Test and Validation Analyst will work for the Leidos Customer Relationship and Compliance Lead but is expected to work independently and accomplish assignments without much direction. The position encompasses being the eIT PMO FDA Validation SME/point of contact, overseeing all validation efforts by developing and maintaining the project’s Food and Drug Administrations (FDA) validation deliverables following applicable guidelines and international standards and methodologies. Perform planning and testing on eIT PMO products ensuring these systems are operating as expected. Coordinate testing activities with the Product Leads on the software patches, upgrades, and new products. Ensure all cybersecurity updates follow the Change and Release Management process.

• Work schedule must be flexible and will require after-hours work during scheduled downtimes.

What you will do:

Primary Duties:

• Be the project Submit Matter Expert (SME) for all things FDA Validation related to the project’s Information Technology portfolios and products. Create and present FDA Validation training materials and ensure project compliance.

• Design, write, and execute software implementation test plans, test reports, and test scripts to test requirements and functionality of application software.

• Ensure all software/hardware changes and testing process maintain FDA 21 CFR Part 11 validated state of application. Work in conjunction with USAMRDC Office of Regulatory Activities (ORA) to maintain a validated state throughout the change management process.

• Oversee deviations and product problem reports are properly documented.

• Work closely with Product Leads and System Administrators in determining what areas are to be tested as well as Requirements Analyst to ensure requirements are testable.

• Write and oversee the execution of system validation plans and reports.

• Ensure complete documentation of test and validation process is done in a quality manner.

• Utilize the internal electronic document management system to store all electronic documents.

• Write/edit SOPs, work instructions, training presentations, and other documents to refine and streamline processes at the eIT PMO.

• Provide annual training to eIT PMO staff on testing and validation.

• Mentor other Test/Validation Analysts.

Specific Duties:

• Ensuring procedures and software have been implemented in a quality manner to support FDA 21 CFR Part 11 regulations and FDA GAMP 5 risk management methodology.

• Review change requests and change proposals with regard to effects on validated state of product and determine level of testing required to maintain validated state.

• Maintain standard test methods and procedures to verify software applications.

• Work with Product Leads to determine an efficient testing and release strategy when bundling changes.

• Communicate across teams the test plan/report results and compare against requirements to identify defects and ensure proposed design meets functional and performance specifications.

• Recreate identified defects to assist in the troubleshooting/resolution process in a timely manner.

• Review system level documentation including Requirements Traceability Matrix, Detailed Design Document, System Configuration Specification, and Version Control List.

What you need to succeed:

• U.S. citizenship or foreign national certification is required.

• A Bachelor’s degree and 4-8 years of prior relevant experience or Master’s degree with 2-6 years of experience to include 2-4 years in testing and validation. Additional years of experience will be considered in lieu of degree.

• Must have experience with Food and Drug Administration (FDA) 21 CFR Regulations and GAMP 5 guidelines.

• Must be proficient in Microsoft Office Suite programs including Word, Excel, Adobe, PowerPoint, Project, and Visio.

• Ability to work efficiently when remote and complete tasks on time.

• Must be able to successfully complete a NACI background investigation.

• Strong attention to details with ability to learn quickly and work effectively with others and on your own in a fast-paced environment.

• Strong verbal and written communication skills are necessary to interface with customers and technical teams on information management and FDA processes.

Desired Qualifications:

• Experience with USAMRDC, DoD, and/or Army regulations Quality Assurance Policies and Procedures.

• Understand the DoD Acquisition Process.

• Knowledge of MRDC customers, processes, and guidelines.

• Familiarity with good documentation practices.

Pay Range:

The Leidos pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.