2 Jobs Hiring

Clearance Required: Secret   Job Duties:  Perform as individual contributor and Analyst Lead for advanced concepts development projects. This includes directing the activities of junior level engineers. Contribute in full lifecycle development of advanced concepts. Position is responsible for performing the evaluation of advanced missile defense command and control capabilities to provide highly innovative and ingenious solutions to complex technical problems. Including defining and coordinating analysis objectives and metrics for various experimental prototypes, performing the associated analysis, and serve as the X-Lab spokesperson on advanced projects when briefing results to the customer. Actions are critical to achieving X-Lab organizational objectives and directly affect the impact of X-Lab technological capability. Assignments are often self-initiated with consultation and agreement of X-Lab leadership. The Lead Analyst will provide oversight of maintenance and improvements to the analysis tool suite. Support advanced concept demonstrations during live and simulated MDA test events. Non-standard work hours are highly likely during event execution and a small amount of travel may be required. Requirements Experience Requirements: The X-Lab is a very fast paced and dynamic environment. The X-Lab is responsible for developing and integrating future-capability prototypes for the Ballistic Missile Defense System (BMDS) including Sensor/Weapon Integration, Algorithm Development, User Interface Development and other critical leading-edge missile defense technologies. The X-Lab has a need to augment the team with a senior systems engineer and analysis lead that holds at least a Secret clearance with a TS/SCI being preferable and possesses demonstrable skills in the following areas: - Analysis tool development using MATLAB, Excel, S-Code, Satellite Toolkit (STK), etc. - Perform verification and validation of systems (functional and performance) - Full cycle systems engineering of new capabilities - System and subsystem decomposition - Use case, system requirements, performance specification development, and UML modeling - System interface design & Interface Control Document development - Conducting and participating in peer reviews - Good communication skills (written and oral) - Leadership of a team composed of multiple disciplines This position will focus on and lead the analysis of R&D systems in C2BMC and will contribute to other ongoing XLab projects as needed. Including the assessment on how the C2BMC prototype system performs by identifying high level objectives and refining into an integrated set of metrics, analysis tool development, assessment of experimental data, generating and presenting customer-quality products containing analytical observations. The Lead Analyst will apply  these results to identify and work to enhance the program for future operations. The Lead Analyst must possess expertise in a technical discipline related to systems engineering, analysis, or missile defense. The Lead Analyst should be comfortable with rapidly changing requirements, design challenges that require novel solutions, fast-paced activities, and tight deadlines. The Lead Analyst must have [12+] years of experience leading or contributing to an integrated team environment with other systems, software, and specialty engineers to develop solutions that includes a background in all aspects of the analysis life cycle. The Lead Analyst should have experience with identification of analysis objectives, metric generation, data assessment, and presentation of the results. The Lead Analyst should have demonstrated the ability to analyze high level customer needs and defined a structured and logical approach to refine the objectives and analysis requirements. The Lead Analysist should have demonstrated the ability to communicate effectively, developed and scripted analysis tools, clearly present technical approaches and findings, and have experience in writing and implementing analysis plans within a project. Ideally, the Lead Analyst will have experience in working on IRAD-type projects. Desired Experience: Integration practices and methods Test driven development and continuous integration Ability to extract data to support analysis Operating systems experience with Windows & Unix/Linux Algorithm design and implementation DoD Architecture Framework (DoDAF) Physics & mechanics of powered and ballistic missile flight Theory and application of the BMDS Theory and application of command and control systems Theory and application of track correlation algorithms Probability theory and optimal state estimation Familiarity with Link-16, including content, transmission rules, etc. Coding skills a plus (Java, C++, and shell scripts) Excellent communication skills (written and oral)   Essential Requirements: US Citizenship is required.

SENIOR VALIDATION ENGINEER JOB DESCRIPTION   Scope of Role &  Responsibilities:  Work under the direction the Project and Validation Managers, the Senior Validation Engineer will:   Draft, lead reviews and approval of Engineering Commissioning protocols (FAT, SAT etc.) and validation protocols (IOQ and PQ protocols) to support new manufacturing line installation. Support Execute the IOQ and PQ protocols. Have expertise in equipment validation and Computer System Validation Manage, track and lead closure of discrepancies and deviations of executed validation protocols Draft and lead reviews and approval of and validation summary reports Support vendor activities on Site during installation, commissioning, SAT and pre-IOQ protocols executions. Support updating project ESD (Engineering Specification Document) and related SOP’s Develop and execute validation protocols to run new autoclave cycle for new machine parts. Participate in project team meetings. Provide periodic progress reports and status updates to Project and Validation Managers. Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards.  Track and execute computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned. Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).Work with the data integrity team to ensure compliance in creation and execution of validation activities. Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans, Working knowledge of statistical analysis – Six Sigma Green Belt or equivalent.   Qualifications:   (1) BS in Engineering or Life Sciences. (2) Minimum 7 - 10 years of experience in pharma and medical devices commissioning and validation. (3) Experience working in capital project environment – desired. (4) Thorough knowledge in cGMP and FDA regulations. (4) Strong technical skills. (5) Hands-on-experience writing and executing IOPQ protocols. (6) Strong communication skills (open, direct, timely, transparent and factual). (7) Self-driven, self-managed, self-reliant and dependable. (8) Works well in high-performance teams and schedule constraints. (9) Six Sigma Certified (Greenbelt) or equivalent – desired.