Biosafety Lab Level (BSL3) Certification Support

NIKA is hiring for a Biosafety Lab Level (BSL3) Certification Support to support our client in Weilerbach, Germany. The role is contingent upon contract award.

Named a Top Workplace by the Washington Post, NIKA is a well-established company that is focused on growth within an entrepreneurial environment. We work with governments to operate and manage their real property. Our operations management, engineering, and project management services provide our customers with value and expertise to ensure operational readiness for complex and mission-critical facilities. NIKA benefits include PTO, holidays, medical/dental/vision insurance, 401k matching, and an understanding of work/life balance.

Job Description:

The BSL3 Certification Support specialist will provide technical and regulatory expertise to support certification and operational permitting of the existing LRMC Biosafety Level Three (BSL3) laboratory and transition of BSL3 operations to ROBMC.

Responsibilities include:

• Coordinate with U.S. Forces to obtain certification of the existing LRMC BSL3 laboratory.
• Develop the operational plan for the existing BSL3 laboratory.
• Prepare documentation required for operational permitting.
• Prepare and submit the associated application for operational permitting to the appropriate German and U.S. authorities.
• Attest that the BSL3 laboratory complies with applicable Technische Regeln für Biologische Arbeitsstoffe (TRBA 100) requirements.
• Clarify requirements applicable to the U.S. Forces for obtaining the BSL3 permit to operate.
• Address risk-assessment requirements in both U.S. and German formats.
• Coordinate with German and U.S. permitting authorities.
• Interface with the Bundeswehr and other permitting authorities as required.
• Provide technical and regulatory coordination throughout the certification process.
• Develop documentation necessary to transition BSL3 operations and commence BSL3 operations at ROBMC.

• Specialized expertise in Biosafety Level Three (BSL3) laboratory operations, certification, and permitting.
• Knowledge of TRBA 100 requirements.
• Knowledge of applicable U.S. and German biosafety and laboratory requirements.
• Understanding of U.S. and German regulatory and permitting processes applicable to BSL3 laboratories.
• Ability to prepare BSL3 operational plans.
• Ability to prepare technical, regulatory, certification, and permitting documentation.
• Ability to conduct or support risk assessments using applicable U.S. and German formats.
• Ability to coordinate with U.S. Forces, German authorities, the Bundeswehr, and other regulatory stakeholders.
• Ability to support transition of laboratory operations into a new medical facility.
• Strong technical communication, documentation, and coordination skills.
• Ability to travel as required to support certification, permitting, and transition activities.

• MUST be US citizen and have ability to obtain security clearance