Ke`aki Technologies, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Ke`aki Technologies offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.
Ke`aki Technologies has an exciting opportunity for two Bioengineers . The positions will be located at the Omnibus Program and Engineering Technical Support Center (OPETS) located in Ft. Detrick, MD and Ft. Belvoir, VA. This position requires a security clearance and a signed confidentiality agreement.
Please note: This position is contingent upon award.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- Serve as an advisor on all aspects of bioengineering, medical countermeasures, drug development, and portfolio management, to include bioengineering efforts, industry best practices, strategic relations, and medical transition activities.
- Perform support and oversight functions from product conceptualization through implementation, including:
o Understanding capability gaps and assisting in setting project- and product-level strategy and priorities, ensuring portfolios are mapped to program goals
o Providing expert analysis and engineering support of the design and development, installation and qualification, operation and validation of flexible, modular, single use system technologies in relation to biopharmaceutical manufacturing
o Directing the activities of other bioengineers, as required, d. Advising the program team on risk assessment and risk management, technology portfolio and pipeline management, business and contracting strategies, technology transfers, and intellectual property management
o Implementing and tracking EVM systems appropriate for pharmaceutical development within the constraints of the FDA approval process
o Reviewing and assessing documentation (e.g., Alignment Charts; Research, Development and Acquisition Plans; Technology Development Strategy; TEMP; Life Cycle Management Plan; Acquisition Strategy; Modernization Plans, etc.)
o Participating in Integrated Capability Teams and serve as technical point of contact, as required
o Attending medical technical conferences (e.g., Medical Research Institute of Chemical Defense and Armed Forces Radiological Research Institute)
o Performing discrete, special interest efforts to solve problems and complete studies
o Participating in medical Focus Innovative Technologies (FITs), Solicitations for Efforts Exploratory Development (SEEDs), and related efforts with Joint Science and Technology Office (JSTO) and other agencies
- Establish and maintain relationships with relevant internal and external stakeholders in the CBD community (i.e., combat and materiel developers, systems engineers, test and evaluation entities, Industry, DoD, Department of Health and Human Services Biomedical Advanced Research and Development Authority, JSTO, FDA, and academic partners in order to evaluate current and emerging medical technologies and facilitate cross-communication regarding program priorities and courses of action.
- Assist in determining the strategic direction of the organization, participating in technology demonstrations and directing Science and Technology (S&T) transitions.
Job Type: Full-Time
- Successful completion of a full course of study in an accredited college or university leading to a Master’s Degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, and DAU Level III certification in PM or SPRDE, or the civilian equivalent, are required. A combination of a Bachelor’s Degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, DAU Level III certification in PM or SPRDE, and 8 years of experience may be substituted for a Master’s Degree.
- 8 years of general experience and 5 years of experience in a program office or similar organization.
- Expert knowledge in the development processes, relative to the DoD 5000 systems acquisition process, for medical products and systems is required.
- Experience in tailoring DoD acquisition policies to drug development and bio-surveillance activities.
- Display the ability to perform the following:
o Developing Statements of Work, procurement requests, market surveys, and RFIs
o Preparing and staffing recurring reports and milestone decision briefings
o Creating resource-loaded schedules
o Planning and executing IBRs and assisting with preparation of briefing charts to support internal and external Program Management Reviews
FLSA Status: Non-Exempt
Ke`aki Technologies LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.
For additional information on Ke`aki Technologies, LLC, please visit www.keakitech.com.
Ke`aki Technologies, LLC is proud to be an Equal Opportunity Employer/Affirmative Action Employer (EEO/AA) and applicants will be considered without regard to race, color, religion, age, sex, disability, national origin, marital status, or genetic information.